An Open-label Extension Study To Evaluate Safety Of PF-06252616 In Boys With Duchenne Muscular Dystrophy

NCT02907619 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: B51610042016-001615-21
• Study Type: interventional
• Target: 59
• Locations: 5 countries
• Sites: 47

Brief Summary

This study is an open-label extension to protocol B5161002 and will provide an assessment of the long term safety, efficacy, pharmacodynamics and pharmacokinetics of intravenous dosing of PF 06252616 in boys with Duchenne muscular dystrophy. Approximately 105 eligible subjects will be assigned to receive a monthly individualized maximum tolerated dose based on their tolerability profile/data from B5161002. This study will not contain a placebo comparator. Subjects will undergo safety evaluations (Laboratory, cardiac monitoring, physical exams, x-ray, MRI), functional capacity evaluations (4 stair climb, range of motion, strength testing, Northstar Ambulatory Assessment, upper limb functional testing, six minute walk test and pulmonary function tests) and pharmacokinetic testing.

Conditions

Duchenne Muscular Dystrophy

Keywords

Duchenne muscular dystrophy, myostatin, open-label

Outcome Measures

Primary Outcomes (28)

• Number of Participants With Dose Reduced or Temporary Discontinuation Due to AEs

  An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment or usage. Treatment-related AEs were determined by the investigator. The number of participants with dose reduced or temporary discontinuation due to both all-causality and treatment-related AEs are presented below.

  2 Years

• Number of Participants With Severe Treatment-Emergent Adverse Events (TEAEs)

  An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment or usage. TEAEs were AEs occurred following the start of treatment or AEs increasing in severity during treatment. Severe TEAEs were TEAEs that interfered significantly with participants' usual function. Treatment-related TEAEs were determined by the investigator. The number of participants with severe all-causality and treatment-related TEAEs are presented below.

  2 Years

• Number of Participants Who Discontinued From the Study Due to TEAEs

  An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment or usage. TEAEs were AEs occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator. The number of participants who discontinued from the study due to both all-causality and treatment-related TEAEs are presented below.

  2 Years

• Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology

  Hematology evaluation included: hemoglobin, hematocrit, red blood cell (RBC) count, platelets, RBC morphology, white blood cell (WBC) count, absolute lymphocytes, absolute atypical lymphocytes, absolute total neutrophils, absolute total neutrophils count, absolute band cells, absolute basophils, absolute eosinophils and absolute monocytes. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. (ULN=Upper Limit of Normal; LLN=Lower Limit of Normal).

  2 Years

• Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Coagulation

  Coagulation evaluation included activated partial thromboplastin time (aPTT) and prothrombin time (PT). (ULN=Upper Limit of Normal). Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004.

  2 Years

• Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Liver Function

  Liver function evaluation included: total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), alkaline phosphatase, total protein, albumin and glutamate dehydrogenase. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. (LLN=Lower Limit of Normal; ULN=Upper Limit of Normal).

  2 Years

• Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Renal Function

  Renal function evaluation included: blood urea nitrogen (BUN), creatinine and uric acid. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. (ULN=Upper Limit of Normal).

  2 Years

• Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes

  Electrolytes evaluation included: sodium, potassium, chloride, calcium, phosphate and bicarbonate. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. (LLN=Lower Limit of Normal, ULN=Upper Limit of Normal).

  2 Years

• Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones

  Hormone evaluations included free thyroxine (T4), thyroid stimulating hormone (TSH), lutenizing hormone (LH), follicle stimulating hormone (FSH), and androstenedione. Numbers of participants with abnormalities of LH, FSH and androstenedione were reported in different age groups. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. (LLN=Lower Limit of Normal, ULN=Upper Limit of Normal).

  2 Years

• Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry

  Clinical chemistry evaluation included glucose, creatine kinase (CK), troponin I, amylase, iron binding capacity, unsaturated iron binding capacity, transferrin saturation, iron and ferritin. Number of participants with iron abnormalities was reported in different age groups. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. (LLN=Lower Limit of Normal, ULN=Upper Limit of Normal).

  2 Years

• Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis

  Urinalysis Microscopy included: urine red blood cell (RBC), urine white blood cell (WBC), urine uric acid crystals, urine calcium oxalate crystals, urine amorphous crystals, urine bacteria, urine microscopic exam. Urinalysis Dipstick included: urine pH, urine glucose, urine ketones, urine protein, urine blood/hemoglobin, urine nitrite, urine leukocyte esterase. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004.

  2 Years

• Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Fecal Blood

  Number of participants with blood detected in fecal samples is presented. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. (ULN=Upper Limit of Normal).

  2 Years

• Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline

  Participants were asked to fast for at least 8 hours prior to collection of blood to evaluate serum iron, serum ferritin and % transferrin saturation. The unit of iron was mcg/dL; the unit of ferritin was ng/mL; the unit of %transferrin saturation was %. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004.

  Baseline, Weeks 13, 25, 37, 49, 61, 73 and 85.

• Number of Participants With Significant Results of Physical Examinations Including Nose and Throat Mucosal Examinations

  Physical examinations were conducted by a physician, trained physician's assistant, or nurse practitioner as acceptable according to local regulation. A targeted nose and throat mucosal exam was performed to monitor for any signs of mucosal telangiectasias. The clinically significant physical examination results were determined by the investigator.

  2 Years

• Summary of Pubertal Development by Tanner Stage

  Tanner staging was performed before the first dose of this study to monitor for signs of accelerated sexual development. The physical changes in pubertal development (pubic hair, penis and testes) were assessed using the system described by Marshall and Tanner. Stage 1 is preadolescent, Stages 2, 3, and 4 are initiation of puberty and Stage 5 is mature adult. Details about the system can be referred to Tanner JM. Growth at Adolescence. Blackwell Scientific Publications 1962; 2nd edition. Participant's Week 97 visit within study B5161002 (parent study) was collected as screening data. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004.

  Screening, Baseline, Week 49.

• Summary of Testicular Volume

  Testicular volume was used to monitor pubertal development. Participant's Week 97 visit within Study B5161002 (parent study) was collected as screening data in current study. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004.

  Screening, Baseline, Week 49.

• Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - B5161004 Baseline

  The number of participants pre-dose supine blood pressure and pulse rate meeting categorical summarization criteria are recorded in this table. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. (DBP=diastolic blood pressure, SBP=systolic blood pressure; The unit for blood pressure is: mmHg, the unit for pulse rate is: beats per minute \[BPM\])

  2 Years

• Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - Overall Baseline

  The number of participants with data of pre-dose supine blood pressure meeting categorical summarization were recorded in this table. Overall Baseline was defined as the last pre-dose assessment prior to the first day of dosing in study B5161002. (DBP=diastolic blood pressure, SBP=systolic blood pressure; The unit for blood pressure is: mmHg).

  2 Years

• Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - B5161004 Baseline

  QTcF=QT/(60/Hour)\*\*(1/3). Means of replicates were used in the calculations. QT=time between the start of the Q wave and the end of the T wave in the heart's electrical cycle; QTcF=corrected QT (Fridericia correction). All scheduled ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. Baseline was defined as the average of the last triplicate pre-dose measurements prior to Day 1 in B5161004.

  2 Years

• Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - Overall Baseline

  QT=time between the start of the Q wave and the end of the T wave in the heart's electrical cycle; QTcF=corrected QT (Fridericia correction). All scheduled ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. Overall baseline was defined as the average of the last triplicate pre-dose measurements prior to the first day of dosing in study B5161002.

  2 Years

• Number of Participants With Iron Accumulation Data Meeting Categorical Summarization Criteria

  Liver Magnetic Resonance Imaging (MRIs) were sent to an independent central radiology imaging facility for calculation of the average R2\* value which was used to monitor for iron accumulation in the liver. Mean R2\* values had been used in the calculations. Normal: R2\* \<= 75 Hz at 1.5 T or \<=139 Hz at 3.0 T; Above Normal: R2\* \> 75 Hz and \<= 190 Hz at 1.5 T or R2\* \> 139 Hz and \<= 369 Hz at 3.0 T Mild overload: R2\* \> 190 Hz at 1.5 T or R2\* \> 369 Hz at 3.0 T Data from participant's Week 93 visit in Study B5161002 (parent study) were used for screening in the current study.

  Screening and Week 49.

• Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Cardiac MRI - B5161004 Baseline

  The LVEF was the ratio of blood ejected during systole to blood in the ventricle at the end of diastole. LVEF was measured by cardiac magnetic resonance imaging (MRI) or echocardiography. The same method of cardiac imaging was used consistently for each participant. Cardiac MRIs were read by a central imaging vendor, while echocardiograms were read locally (at each site). The table presents the results from cardiac MRIs. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004.

  Baseline and Week 49.

• Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Cardiac MRI - Overall Baseline

  The LVEF was the ratio of blood ejected during systole to blood in the ventricle at the end of diastole. LVEF was measured by cardiac magnetic resonance imaging (MRI) or echocardiography. The same method of cardiac imaging was used consistently for each participant. Cardiac MRIs were read by a central imaging vendor, while echocardiograms were read locally (at each site). The table presents the results from cardiac MRIs. Overall baseline was defined as the last pre-dose assessment prior to the first day of dosing in study B5161002. Week 1 was counted starting from the study treatment in study B5161002.

  Baseline, Weeks 49, 97, 146.

• Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Echocardiogram - B5161004 Baseline

  The LVEF was the ratio of blood ejected during systole to blood in the ventricle at the end of diastole. LVEF was measured by cardiac magnetic resonance imaging (MRI) or echocardiography. The same method of cardiac imaging was used consistently for each participant. Cardiac MRIs were read by a central imaging vendor, while echocardiograms were read locally (at each site). The table presents the results from echocardiograms. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004.

  Baseline, Week 49.

• Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Echocardiogram - Overall Baseline

  The LVEF was the ratio of blood ejected during systole to blood in the ventricle at the end of diastole. LVEF was measured by cardiac magnetic resonance imaging (MRI) or echocardiography. The same method of cardiac imaging was used consistently for each participant. Cardiac MRIs were read by a central imaging vendor, while echocardiograms were read locally (at each site). The table presents the results from echocardiograms. Overall baseline was defined as the last pre-dose assessment prior to the first day of dosing in study B5161002. Week 1 was counted starting from the study treatment in study B5161002.

  Baseline, Weeks 49, 97, 146.

• Bone Age to Chronological Age Ratio

  Bone age assessment was evaluated by the ratio of the bone age to the chronological age using the X rays of the hand and wrist. Ratio of bone age to chronological age was calculated by bone age/chronological age at scan date. Chronological age at scan date was calculated by (scan date - date of birth + 1)/365.25. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004.

  Baseline and Week 49.

• Whole Body and Spine DXA: Bone Mineral Density Z-Score, Height Adjusted Over Time

  Bone mineral density (BMD) was monitored by dual energy x-ray absorptiometry (DXA). DXA scans were obtained to evaluate bone mineral density of the spine and whole body without head. The height adjusted Z-score presented below is the number of standard deviations which compares the BMD of the participant to the average BMD matched for their age, sex and ethnicity. If the Z-score was -2 standard deviations or lower, the result was "below the expected range for age". If the Z-score was above -2 standard deviations, the result was "within the expected range for age".

  Screening (Week 97 visit within parent study B5161002) and Week 49

• Number of Participants With Suicidal Ideation or Suicidal Behavior

  The Columbia Suicide Severity Rating Scale (C-SSRS) was performed to identify the risk of suicide ideation or behavior. C-SSRS was conducted with the participant's caregiver/legal guardian on the participant's behalf throughout the study, rather than administering this evaluation directly with the study participants. If at any visit the participant endorsed a 4 or 5 on the C-SSRS ideation section or reported any suicidality behavior, then an evaluation of suicide risk (risk assessment) had to be completed and the participant must have been discontinued. The significant result of C-SSRS was determined by the investigator.

  2 Years

Secondary Outcomes (22)

• Change From Baseline on the 4 Stair Climb (4SC) - B5161004 Baseline

  Baseline, Weeks 13, 25, 49, 73.

• Change From Baseline on the 4SC - Overall Baseline

  Baseline, Weeks 9,17,25,33,41,49,57,65,73,81,89,97,110,122,146,170.

• Change From Baseline on the Forced Vital Capacity (FVC) - B5161004 Baseline

  Baseline, Weeks 13, 25, 49 and 73.

• Change From Baseline on the FVC - Overall Baseline

  Baseline, Weeks 9,17,25,33,41,49,57,65,73,81,89,97,110,122,146,170.

• Change From Baseline on the Northstar Ambulatory Assessment (NSAA) Score - B5161004 Baseline

  Baseline, Weeks 13, 25, 49, 73.

Study Arms (1)

PF-06252616

EXPERIMENTAL

Either 5mg/kg, 20mg/kg or 40mg/kg will be assigned to a subject based on their maximum tolerated dose from B5161002

Biological: PF-06252616

Interventions

PF-06252616 BIOLOGICAL

Either 5mg/kg, 20mg/kg or 40mg/kg will be assigned to a subject based on their maximum tolerated dose from B5161002

PF-06252616

Eligibility Criteria

• Age: 6 Years - 18 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subjects with Duchenne muscular dystrophy who enrolled and completed study B5161002.
• Signed and dated informed consent document (ICD) indicating that the subject's parent or legal guardian/caregiver has been informed of all pertinent aspects of the study.
• Subjects and their legal guardians/caregivers who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
• Subject have;
• Adequate hepatic function on screening laboratory assessments
• GLDH less than 20 units/liter (2 x upper limit of normal \[ULN\])
• Iron content estimate on the liver MRI within the normal range.

You may not qualify if:

• Unwilling or unable (eg, metal implants) to undergo examination with closed MRI.
• All male subjects who are able to father children and are sexually active and at risk for impregnating a female partner, who are unwilling or unable to use a highly effective method of contraception. In addition, all sexually active male subjects who are unwilling or unable to prevent potential transfer of and exposure to drug through semen to their partners by using a condom consistently and correctly. .
• Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the Investigator, or subjects who are related to Pfizer employees directly involved in the conduct of the study.
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation.
• Participation in other studies involving investigational drug(s), with the exception of B5161002.
• History of allergic or anaphylactic reaction to a therapeutic or diagnostic protein or additives of this investigational product.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (47)

David Geffen School of Medicine at UCLA/UCLA Neurology

Los Angeles, California, 90095, United States

Location

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Ronald Reagan UCLA Pharmacy

Los Angeles, California, 90095, United States

Location

UCLA (David Geffen School of Medicine), Department of Orthopedic Surgery

Los Angeles, California, 90095, United States

Location

UCLA Clinical & Translational Research Center

Los Angeles, California, 90095, United States

Location

University of California, Davis Medical Center

Sacramento, California, 95817, United States

Location

University of Iowa ICTS, Clinical Research Unit

Iowa City, Iowa, 52242, United States

Location

Kennedy Krieger Institute Out-patient Center

Baltimore, Maryland, 21205, United States

Location

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Johns Hopkins Investigational Drug Service

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Minnesota Masonic Children's Hospital

Minneapolis, Minnesota, 55454, United States

Location

(For Drug deliveries) IDS Pharmacy

Minneapolis, Minnesota, 55455, United States

Location

St. Louis Childrens's Hospital

St Louis, Missouri, 63110, United States

Location

Duke University Medical Center, Lenox Baker Children's Hospital

Durham, North Carolina, 27705, United States

Location

Duke University, Investigational Drug Pharmacy

Durham, North Carolina, 27710, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

Center for Clinical and Translational Sciences

Salt Lake City, Utah, 84108, United States

Location

Utah Center for Advanced Imaging and Research (UCAIR)

Salt Lake City, Utah, 84108, United States

Location

Investigational Drug Services

Salt Lake City, Utah, 84112, United States

Location

Utah Program for Inherited Neuromuscular Disorder

Salt Lake City, Utah, 84112, United States

Location

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

Location

University of Utah School of Medicine

Salt Lake City, Utah, 84132, United States

Location

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

UBC Children's and Women's Health Centre of British Columbia

Vancouver, British Columbia, V6H 3V4, Canada

Location

Children's Hospital- London Health Sciences Centre

London, Ontario, N6A5W9, Canada

Location

Centre de Readaptation Marie Enfant (CRME)

Montreal, Quebec, H1T 1C9, Canada

Location

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

UOC Farmacia - Istituto Gianna Gaslini,

Genova, 16147, Italy

Location

UOC Medicina Fisica Riabilitativa - Istituto G. Gaslini

Genova, 16147, Italy

Location

UOC Neurologia Pediatrica e Malattie Muscolari Istituto Gianna Gaslini

Genova, 16147, Italy

Location

UOC Radiologia - Istituto Gianna Gaslini,

Genova, 16147, Italy

Location

UOS Dipartimentale Endocrinologia Clinica Sperimentale - Ist.

Genova, 16147, Italy

Location

Dipartimento Pediatrico Universitario-Ospedaliero Endocrinologia

Rome, 00150, Italy

Location

Farmacia Ospedaliera, IRCCS Ospedale Pediatrico Bambino Gesu

Rome, 00165, Italy

Location

IRCCS Ospedale Pediatrico Bambino Gesu - Centro Trials

Rome, 00165, Italy

Location

U.O. Malattie Neuromuscolari e Neurodegenerative, IRCCS Ospedale Pediatrico Bambino Gesu

Rome, 00165, Italy

Location

Hyogo college of medicine hospital

Nishinomiya-shi, Hyōgo, 663-8501, Japan

Location

National Center of Neurology and Psychiatry

Kodaira, Tokyo, 187-8551, Japan

Location

Dubowitz Neuromuscular Centre, Institute of Child Health

London, WC1N 3JH, United Kingdom

Location

Great Ormond Street Hospital

London, WC1N 3JH, United Kingdom

Location

Institute of Genetic Medicine,Muscle Team

Newcastle upon Tyne, NE1 3BZ, United Kingdom

Location

Clinical Research Facility

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

Royal Victoria Infirmary Research Pharmacy

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

Related Publications (1)

• Wagner KR, Abdel-Hamid HZ, Mah JK, Campbell C, Guglieri M, Muntoni F, Takeshima Y, McDonald CM, Kostera-Pruszczyk A, Karachunski P, Butterfield RJ, Mercuri E, Fiorillo C, Bertini ES, Tian C, Statland J, Sadosky AB, Purohit VS, Sherlock SP, Palmer JP, Binks M, Charnas L, Marraffino S, Wong BL. Randomized phase 2 trial and open-label extension of domagrozumab in Duchenne muscular dystrophy. Neuromuscul Disord. 2020 Jun;30(6):492-502. doi: 10.1016/j.nmd.2020.05.002. Epub 2020 May 19.

  PMID: 32522498 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne

Interventions

domagrozumab

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Limitations and Caveats

The study was terminated prematurely due to insufficient efficacy and not due to safety reasons.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: September 20, 2016
• Study Start: October 13, 2016
• Primary Completion: November 22, 2018
• Study Completion: November 22, 2018
• Last Updated: November 23, 2020
• Results First Posted: November 25, 2019

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share

Locations

JP (2); IT (9); CA (5); GB (5); US (26)