Viral Kinetics in HCV Clearance in Subjects With Hemophilia

NCT01704521 | Completed Phase 1 Results DMC

• 2 other identifiers: 12053004R34HL109334
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine viral dynamic responses in subjects with chronic hepatitis C and hemophilia when treated with pegylated interferon + ribavirin and telaprevir.

Conditions

Chronic Hepatitis C; Hemophilia

Keywords

Hepatitis C; HCV; Hemophilia

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Sustained Virological Response at Week 12 (SVR12)

  Viral kinetic assessment using SVR 12 to either "lead-in" 4 weeks with PegInterferon + Ribavirin or no lead-in, followed by response guided therapy of 24 or 48 weeks based on viral response to treatment. Standard of care treatment stopping rules will be followed with assessment of viral response at week 12 of treatment.

  Post-treatment at week 12

Study Arms (2)

Lead-In

ACTIVE COMPARATOR

Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin for 4 weeks followed by 12 weeks of PegInterferon + Ribavirin + Telaprevir followed by variable duration of PegInterferon + Ribavirin

Drug: PegInterferon; Drug: Ribavirin; Drug: Telaprevir

No Lead-in

ACTIVE COMPARATOR

Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by variable duration of PegIntereron + Ribavirin

Drug: PegInterferon; Drug: Ribavirin; Drug: Telaprevir

Interventions

PegInterferon DRUG

Lead-In; No Lead-in

Ribavirin DRUG

Lead-In; No Lead-in

Telaprevir DRUG

Lead-In; No Lead-in

Eligibility Criteria

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

You may qualify if:

• Hemophilia A or B
• HCV RNA positive (PCR or branched-chain DNA Methods), Genotype 1 (a/b, mixed and unknown subtype)
• Chronic HCV infection evidenced by HCV serology, HCV RNA or liver enzyme abnormalities present at least 6 months prior to enrollment
• Age ≥ 18 years
• Prior HCV treatment naïve or experienced
• HCV viral load detectable during screening period

You may not qualify if:

• Sexually active subjects (both male and female) must agree and commit to the use of a medically acceptable form of contraception for the duration of the study and for 6 months following the last dose of study medication. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices or properly used barrier contraception.
• Hemoglobin \<11
• Pregnancy (during screening period or any time during treatment)
• females, that are planning to become pregnant or are breastfeeding
• males, whose partner is pregnant or is planning to become pregnant
• HIV Infection
• Prior History of:
• Hepatitis B (HBsAG negative - must have documentation of negative results within one year prior to enrollment or during screening period if not performed in that time window
• History of Homozygotic Genetic Hemochromatosis (at anytime prior to enrollment) with evidence of iron overload requiring phlebotomy,
• Autoimmune markers (antinuclear antibody (ANA) and/or antismooth muscle antibody (ASMA)) \>1:160.
• History of Decompensated liver disease evidenced by any prior history of hepatic encephalopathy (Grade 2 or higher), ascites, variceal bleeding; Platelet count \< 100,000
• Active thyroid disease (OK if on thyroid replacement with normal thyroid-stimulating hormone (TSH); if TSH abnormal must have normal free thyroid index)
• Chronic renal insufficiency, defined as creatinine clearance \< 50 ml/min. (estimated by Modification of Diet in Renal Disease (MDRD) formula)
• Life-threatening disease processes that could preclude completion of trial in opinion of investigator.
• Any condition which the investigator feels will preclude safe completion of the treatment regimen including severe psychiatric disorders, active alcohol or recreational drug abuse.

Sponsors & Collaborators

• Kenneth Sherman: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Vertex Pharmaceuticals Incorporated: collaborator
• Genentech, Inc.: collaborator

Study Sites (1)

UC Physicians Company

Cincinnati, Ohio, 45267, United States

Location

MeSH Terms

Conditions

Hepatitis C, Chronic; Hemophilia A; Hepatitis C

Interventions

Ribavirin; telaprevir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Kenneth E. Sherman, MD. PhD
• Organization: University of Cincinnati

kenneth.sherman@uc.edu

513-558-3918

Study Officials

• Kenneth E Sherman, MD, PhD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Kenneth E. Sherman, MD, PhD

Study Record Dates

• First Submitted: October 5, 2012
• First Posted: October 11, 2012
• Study Start: December 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: April 6, 2015
• Results First Posted: April 6, 2015

Record last verified: 2015-03

Locations

US (1)