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

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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.


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
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