Trial record 3 of 6 for:
Hemophilia | Open Studies | NIH, U.S. Fed
Viral Kinetics in HCV Clearance in Subjects With Hemophilia (HCV/Hemophilia)
This study is currently recruiting participants.
Verified January 2013 by University of Cincinnati
Sponsor:
Kenneth Sherman
Collaborators:
Vertex Pharmaceuticals Incorporated
Genentech
Information provided by (Responsible Party):
Kenneth Sherman, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01704521
First received: October 5, 2012
Last updated: January 15, 2013
Last verified: January 2013
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Purpose
This study will examine treatment response in subjects with chronic hepatitis C and hemophilia with pegylated interferon + ribavirin and telaprevir.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C With Hemophilia |
Other: Lead -In- PegInterferon + Ribavirin (4 weeks); PegInterferon + Ribavirin + Telaprevir (12 weeks); PegInterferon + Ribavirin (8 weeks) Other: No Lead-in - No 4-week lead in therapy; PegInterferon + Ribavirin + Telaprevir (12 weeks); PegInterferon+ Ribavirin (12 weeks) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | Viral Kinetic Models of HCV Clearance in Hemophiliacs With Telaprevir |
Resource links provided by NLM:
Further study details as provided by University of Cincinnati:
Primary Outcome Measures:
- Viral Kinetic Models of HCV Clearance in Hemophiliacs with Telaprevir [ Time Frame: Viral kinetics at Week 12 ] [ Designated as safety issue: Yes ]Subjects will be randomized 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.
| Estimated Enrollment: | 20 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Lead -In
Response Guided treatment per standard of care with PegInterferon + Ribavirin for 4 weeks followed by 12 weeks of PegInterferon + Ribavirin + Telaprevir followed by 8 weeks of PegInterferon + Ribavirin.
|
Other: Lead -In- PegInterferon + Ribavirin (4 weeks); PegInterferon + Ribavirin + Telaprevir (12 weeks); PegInterferon + Ribavirin (8 weeks) Other: No Lead-in - No 4-week lead in therapy; PegInterferon + Ribavirin + Telaprevir (12 weeks); PegInterferon+ Ribavirin (12 weeks) |
|
Active Comparator: No Lead -in
Response Guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by 12 weeks of PegInterferon + Ribavirin
|
Other: Lead -In- PegInterferon + Ribavirin (4 weeks); PegInterferon + Ribavirin + Telaprevir (12 weeks); PegInterferon + Ribavirin (8 weeks) Other: No Lead-in - No 4-week lead in therapy; PegInterferon + Ribavirin + Telaprevir (12 weeks); PegInterferon+ Ribavirin (12 weeks) |
Detailed Description:
Previous clinical trials for treatment of chronic hepatitis C have excluded subjects with hemophilia from participating.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01704521
Contacts
| Contact: Susan R Sibert, RN.CCRC | 513-584-0832 | susan.sibert@uc.edu |
| Contact: Diane Daria, RN,BSN | 513-584-0832 | diane.daria@uc.edu |
Locations
| United States, Ohio | |
| University of CIncinnati / Holmes Building | Recruiting |
| Cincinnati, Ohio, United States, 45002 | |
| Contact: Susan R. Sibert, RN,CCRC 513-584-8032 susan.sibert@uc.edu | |
| Principal Investigator: Kenneth E Sherman, MD, PhD | |
Sponsors and Collaborators
Kenneth Sherman
Vertex Pharmaceuticals Incorporated
Genentech
Investigators
| Principal Investigator: | Kenneth E Sherman, MD, PhD | University of Cincinnati |
More Information
No publications provided
| Responsible Party: | Kenneth Sherman, Kenneth E. Sherman, MD, PhD, University of Cincinnati |
| ClinicalTrials.gov Identifier: | NCT01704521 History of Changes |
| Other Study ID Numbers: | 12053004, R34HL109334 |
| Study First Received: | October 5, 2012 |
| Last Updated: | January 15, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Cincinnati:
|
Hepatitis C HCV Hemophilia |
Additional relevant MeSH terms:
|
Hemophilia A Hepatitis Hepatitis A Hepatitis C Blood Coagulation Disorders, Inherited Blood Coagulation Disorders Hematologic Diseases Coagulation Protein Disorders Hemorrhagic Disorders Genetic Diseases, Inborn Liver Diseases Digestive System Diseases Hepatitis, Viral, Human |
Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Ribavirin Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013