Viral Kinetics in HCV Clearance in Subjects With Hemophilia (HCV/Hemophil)
This study has been completed.
Vertex Pharmaceuticals Incorporated
Information provided by (Responsible Party):
Kenneth Sherman, University of Cincinnati
First received: October 5, 2012
Last updated: March 26, 2015
Last verified: March 2015
This study will examine viral dynamic responses in subjects with chronic hepatitis C and hemophilia when treated with pegylated interferon + ribavirin and telaprevir.
Chronic Hepatitis C
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
||Viral Kinetic Models of HCV Clearance in Hemophiliacs With Telaprevir
Primary Outcome Measures:
- Number of Participants With Sustained Virological Response at Week 12 (SVR12) [ Time Frame: Post-treatment at week 12 ] [ Designated as safety issue: Yes ]
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.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||October 2014 (Final data collection date for primary outcome measure)
Active Comparator: Lead-In
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
Active Comparator: No Lead-in
Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by variable duration of PegIntereron + Ribavirin
Previous clinical trials for treatment of chronic hepatitis C have excluded subjects with hemophilia from participating.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- Liver biopsy or non-invasive marker that permits fibrosis staging within 12 months of enrollment. If a biopsy was not performed within 1 year, non-invasive markers may be utilized during screening period. Cirrhosis is not an exclusion factor
- Age ≥ 18 years
- Prior HCV treatment naïve or experienced
- HCV viral load detectable during screening period
- Absence of exclusion criteria
- 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
- Homozygotic alpha-1-anti-trypsin (a1AT) deficiency - documentation of a1AT level <80 (at anytime prior to screening). If <80, phenotype testing should not demonstrate zz phenotype. All other phenotypes are not exclusionary,
- 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.
- Any other significant liver disease or process (to be determined by the investigator). Non-alcoholic fatty-liver disease (NAFLD) is not an exclusion.
- 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.
- Inability to provide informed consent.
- Use of systemic corticosteroids or immunomodulatory drugs within 1 month (Nasal steroids are permitted.)
- Uncontrolled seizure disorder (in opinion of investigator)
- Concurrent autoimmune processes with active disease that may be exacerbated by interferon-based therapies (e.g. Crohn's Disease, Rheumatoid arthritis) in the opinion of the investigator. Psoriasis permitted if controlled with topical medications at the time of study enrollment.
- Use of prohibited medications (as described in the telaprevir package insert) within 14 days of the first dose of study medications
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01704521
|UC Physicians Company
|Cincinnati, Ohio, United States, 45267 |
Vertex Pharmaceuticals Incorporated
||Kenneth E Sherman, MD, PhD
||University of Cincinnati
No publications provided
||Kenneth Sherman, Kenneth E. Sherman, MD, PhD, University of Cincinnati
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 5, 2012
|Results First Received:
||February 3, 2015
||March 26, 2015
||United States: Institutional Review Board
Keywords provided by University of Cincinnati:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 16, 2015
Hepatitis C, Chronic
Blood Coagulation Disorders
Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders
Digestive System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Hepatitis, Viral, Human
RNA Virus Infections
Molecular Mechanisms of Pharmacological Action