Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination and Sofosbuvir + Ribavirin for Subjects With Chronic Hepatitis C Virus (HCV) and Inherited Bleeding Disorders
Status: | Completed |
---|---|
Conditions: | Hepatitis, Hepatitis, Hepatitis, Hematology, Hematology |
Therapuetic Areas: | Hematology, Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | April 2014 |
End Date: | August 2015 |
A Phase 2b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination and Sofosbuvir + Ribavirin for Subjects With Chronic Hepatitis C Virus (HCV) and Inherited Bleeding Disorders
This study will evaluate the antiviral efficacy, safety, and tolerability of treatment with
ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) for participants with genotypes
1 and 4 hepatitis C virus (HCV) infection and sofosbuvir (SOF) plus ribavirin (RBV) for
participants with genotypes 2 and 3 HCV infection. Participants with an inherited bleeding
disorder and chronic HCV infection (either monoinfected or HIV-1/HCV coinfected) will be
enrolled.
ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) for participants with genotypes
1 and 4 hepatitis C virus (HCV) infection and sofosbuvir (SOF) plus ribavirin (RBV) for
participants with genotypes 2 and 3 HCV infection. Participants with an inherited bleeding
disorder and chronic HCV infection (either monoinfected or HIV-1/HCV coinfected) will be
enrolled.
Inclusion Criteria:
- Hemophilia A, B or C, or Von Willebrand's disease
- Chronic genotype 1, 2, 3 or 4 HCV infection
- HCV RNA ≥ 1000 IU/mL at screening
- Use of protocol specified method(s) of contraception if female of childbearing
potential or sexually active male
- Screening laboratory values within defined thresholds
- For HIV-1/HCV co-infected participants:
- Suppressed HIV-1 RNA on an antiretroviral (ARV) regimen for at least 6 months
prior to screening
- Stable protocol-approved ARV regimen for > 8 weeks prior to screening
- CD4 T-cell count > 200 cells/mm^3 at screening
Exclusion Criteria:
- Clinically-significant illness (other than HCV, inherited bleeding disorder or HIV-1)
or any other major medical disorder that may interfere with subject treatment,
assessment or compliance with the protocol
- Current or prior history of any of the following:
- Hepatic decompensation
- Chronic liver disease of a non-HCV etiology
- Hepatocellular carcinoma (HCC)
- Infection with hepatitis B virus (HBV)
- Pregnant or nursing female
- Prior treatment with inhibitors of NS5A or the NS5B polymerase
- Chronic use of systemically administered immunosuppressive agents
- For HIV-1/HCV co-infected subjects:
- Opportunistic infection within 6 months prior to screening
- Active, serious infection (other than HIV-1 or HCV) requiring parental
antibiotics, antivirals or antifungals within 30 days prior to baseline
We found this trial at
13
sites
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