Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 or 24 Weeks in Genotype 1 or 4 HCV Infected Adults With Sickle Cell Disease
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Anemia, Hepatitis, Hepatitis |
| Therapuetic Areas: | Hematology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/21/2018 |
| Start Date: | March 2, 2015 |
| End Date: | April 18, 2016 |
An Open-Label Study of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 or 24 Weeks in Genotype 1 or 4 HCV Infected Subjects With Sickle Cell Disease
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and
tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for
12 or 24 weeks in adults with genotype 1 or 4 hepatitis C virus (HCV) infection with sickle
cell disease (SCD).
tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for
12 or 24 weeks in adults with genotype 1 or 4 hepatitis C virus (HCV) infection with sickle
cell disease (SCD).
Key Inclusion Criteria:
- Chronic genotype 1 or 4 infected patients with sickle cell disease
- HCV RNA ≥ 1,000 IU/mL at screening
- Cirrhosis determination by transient elastography
- Screening laboratory values within defined thresholds
- Use of two effective contraception methods if female of childbearing potential or
sexually active male
Key Exclusion Criteria:
- Pregnant or nursing female
- Co-infection with HIV or hepatitis B virus (HBV)
- Current or prior history of clinical hepatic decompensation
- Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved
skin cancers)
- History of clinically significant illness or any other medical disorder that may
interfere with treatment, assessment or compliance with the protocol
Note: Other protocol defined inclusion/Exclusion criteria may apply.
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