Status:
COMPLETED
Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 or 24 Weeks in Genotype 1 or 4 HCV Infected Adults With Sickle Cell Disease
Lead Sponsor:
Gilead Sciences
Conditions:
Hepatitis C Virus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
March 2 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 18 2016
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02301936
Start Date
March 2 2015
End Date
April 18 2016
Last Update
November 19 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Lutherville, Maryland, United States