A Prospective Non-Interventional Study Protocol With Primary Data Collection - Assessment Of The Long Term Treatment Outcomes Of Genotropin Treatment In Growth Hormone Deficiency (GHD) Patients

NCT01947894 | Completed Results FDA Drug

• 2 other identifiers: A6281313SWEGHO
• Study Type: observational
• Target: 377
• Locations: 1 country
• Sites: 12

Brief Summary

The purpose of this study is to assess the long term treatment outcomes of Growth Hormone treatment in patients who are prescribed and treated with Genotropin. Also, plan to determine the relationships between clinical status, dosage schedule and response to Genotropin treatment. This study will also contribute to our knowledge of adult Growth Hormone Deficiency, including transition period in Childhood Onset Growth Hormone Deficiency and its treatment.

Conditions

Growth Hormone Deficiency

Outcome Measures

Primary Outcomes (1)

• Number of Participants Classified According to Insulin-like Growth Factor (IGF-I) Assessments

  IGF-I along with growth hormone helps promote normal bone and tissue growth and development. Categories for assessment for participant's post-baseline IGF-I values: (1) IGF-I LLN = if any of assessments of IGF-I post-baseline visit was lower than lower limit of normal (LLN); (2) IGF-I ULN = If any of assessments of IGF-I post-baseline visit was greater than upper level of normal (ULN); (3) IGF-I unknown = no IGF-I reported; (4) Within reference range = IGF-I levels within normal range. Following is normal reference range of IGF-I in nanogram per milliliter. 18 Years of age (Y): Male =162-541, Female =170-640; 19 Y: Male =138-442, Female =147-527; 20 Y: Male =122-384,Female =132-457; 21-25 Y=116-341; 26-30 Y=117-321; 31-35 Y=113-297; 36-40 Y=106-277; 41-45 Y =98-261; 46-50 Y=91-246; 51-55 Y=84-233; 56-60 Y=78-220; 61-65 Y=72-207; 66-70 Y=67-195; 71-75 Y=62-184; 76-80 Y=57-172; \>80 Y=53-162. There was no differentiation for male and female in normal range of IGF-I after 20 years of age.

  Up to 5 years (after baseline visit)

Secondary Outcomes (18)

• Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Baseline up to 5 years

• Number of Treatment Related Adverse Events

  Baseline up to 5 years

• Number of Adverse Events Leading to Withdrawal of Genotropin Treatment

  Baseline up to 5 years

• Number of Participants Who Discontinued Study Due to Adverse Events

  Baseline up to 5 years

• Weight of Participants at Baseline, Years 1, 2, 3, 4 and 5

  Baseline, Year 1, 2, 3, 4, 5

Study Arms (1)

Adult Growth Hormone deficient Patients

Patients with GHD on Genotropin® replacement therapy.

Other: Non Interventional Study

Interventions

Non Interventional Study OTHER

Non Interventional Study

Adult Growth Hormone deficient Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients wiht Growth Hormone Deficiency

You may qualify if:

• Adult patients of 18 years of age and above and fulfilling one of the three alternatives a-c below;
• Newly diagnosed with GHD according to the current medical standard.
• Diagnosed with GHD before 2013 and previously treated with Genotropin and followed in KIMS®.
• Transition patients diagnosed with CO-GHD before 2013.
• Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

You may not qualify if:

• Patients who participate in any concurrent clinical interventional trial where a non-authorized or authorized study medication is used, during their participation in Swedish KIMS® Xtended. Concurrent studies which do not include any study interventional items (whether medications or devices) are allowed.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (12)

Vastra Gotalands Regionen

Skövde, Skaraborg, 541 85, Sweden

Location

Landstinget Dalarna

Falun, 791 82, Sweden

Location

Sahlgrenska University hospital

Gothenburg, 413 45, Sweden

Location

Central Hospital/ Department of Medicine

Kristianstad, 291 85, Sweden

Location

Universitetssjukhuset, EM-kliniken

Linköping, 581 85, Sweden

Location

Ljungby Lasarettet

Ljungby, 341 82, Sweden

Location

University Hospital SUS

Malmo, 205 02, Sweden

Location

Landstinget i Stockholms Lan

Stockholm, 118 83, Sweden

Location

Karolinska Universitetssjukhuset, Kliniken for Endokrinologi

Stockholm, 171 76, Sweden

Location

Akademiska sjukhuset / Medicincentrum, Diabetes- och Endokrinsektionen

Uppsala, 751 85, Sweden

Location

Medicinkliniken, Centrallasarettet Vaxjo

Vaxjo, 351 85, Sweden

Location

Landstinget i Jonkopings Lan

Värnamo, 331 85, Sweden

Location

Related Links

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

MeSH Terms

Conditions

Dwarfism, Pituitary

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

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: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2013
• First Posted: September 23, 2013
• Study Start: November 20, 2013
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: November 20, 2019
• Results First Posted: November 20, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (12)