Chronic Hepatitis C, Hemophilia
Conditions
Keywords
Hepatitis C, HCV, Hemophilia
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.
Detailed description
Previous clinical trials for treatment of chronic hepatitis C have excluded subjects with hemophilia from participating.
Interventions
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Vertex Pharmaceuticals Incorporated
Genentech, Inc.
Kenneth Sherman
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Hemophilia A or B 2. HCV RNA positive (PCR or branched-chain DNA Methods), Genotype 1 (a/b, mixed and unknown subtype) 3. Chronic HCV infection evidenced by HCV serology, HCV RNA or liver enzyme abnormalities present at least 6 months prior to enrollment 4. 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 5. Age ≥ 18 years 6. Prior HCV treatment naïve or experienced 7. HCV viral load detectable during screening period 8. Absence of
Exclusion criteria
9. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Sustained Virological Response at Week 12 (SVR12) | Post-treatment at week 12 | 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. |
Countries
United States
Participant flow
Recruitment details
January 2013 through April 2014 at Digestive Diseases Research / University of Cincinnati
Participants by arm
| Arm | Count |
|---|---|
| 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. | 3 |
| No Lead-in No 4 week lead-in: Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by variable duration of PegInterferon + Ribavirin. | 2 |
| Total | 5 |
Baseline characteristics
| Characteristic | Total | Lead-In | No Lead-in |
|---|---|---|---|
| Age, Continuous | 47 years | 53 years | 37 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 3 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 2 Participants | 2 Participants |
| Region of Enrollment United States | 5 participants | 3 participants | 2 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 5 Participants | 3 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 3 | 2 / 2 |
| serious Total, serious adverse events | 1 / 3 | 0 / 2 |
Outcome results
Primary
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.
Time frame: Post-treatment at week 12
Population: See baseline characteristics
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lead-In | Number of Participants With Sustained Virological Response at Week 12 (SVR12) | 2 participants |
| No Lead-in | Number of Participants With Sustained Virological Response at Week 12 (SVR12) | 2 participants |