Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Chronic HCV and HBV Coinfection

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Gilead Sciences

Status and phase

Completed
Phase 3

Conditions

Hepatitis C Virus Infection

Treatments

Drug: LDV/SOF

Study type

Interventional

Funder types

Industry

Identifiers

NCT02613871
GS-US-337-1655

Details and patient eligibility

About

The primary objectives of this study are to determine the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with chronic genotype 1 or 2 HCV infection who are coinfected with HBV in Taiwan.

Enrollment

111 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

  • Individuals ≥ 40 kg in weight with chronic genotype 1 or 2 HCV and HBV coinfection
  • Individuals must not be taking or requiring treatment with HBV antiviral therapy at screening. For participants that are HBV treatment experienced, the most recent treatment must have been completed at least 6 months prior to Day 1.
  • Cirrhosis determination by Fibroscan
  • Screening laboratory values within defined thresholds
  • Use of two effective contraception methods if female or male is of childbearing potential

Key Exclusion Criteria:

  • Current or prior history of clinically-significant illness or any other major medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol
  • Pregnant or nursing female
  • Infection with human immunodeficiency virus (HIV) or hepatitis delta virus (HDV)
  • Hepatocellular carcinoma (HCC) or other malignancy
  • Current or prior history of clinical hepatic decompensation

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

111 participants in 1 patient group

LDV/SOF
Experimental group
Description:
LDV/SOF FDC for 12 weeks
Treatment:
Drug: LDV/SOF

Trial contacts and locations

11

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Data sourced from clinicaltrials.gov

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