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Comparison of Sofosbuvir/Velp...

Comparison of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 12 Weeks in Adults With Chronic Genotype 2 HCV Infection

NCT ID: NCT02220998

Last Updated: 2018-11-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

269 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-09-30

Brief Summary

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The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks compared to treatment with sofosbuvir (SOF) plus ribavirin (RBV) for 12 weeks in participants with chronic genotype 2 hepatitis C virus (HCV) infection.

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Detailed Description

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Conditions

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Hepatitis C Virus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SOF/VEL

SOF/VEL FDC for 12 weeks

Group Type EXPERIMENTAL

SOF/VEL

Intervention Type DRUG

SOF/VEL (400/100 mg) FDC tablet administered orally once daily

SOF+RBV

SOF+RBV for 12 weeks

Group Type EXPERIMENTAL

SOF

Intervention Type DRUG

SOF 400 mg tablet administered orally once daily

RBV

Intervention Type DRUG

RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Interventions

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SOF/VEL

SOF/VEL (400/100 mg) FDC tablet administered orally once daily

Intervention Type DRUG

SOF

SOF 400 mg tablet administered orally once daily

Intervention Type DRUG

RBV

RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Intervention Type DRUG

Other Intervention Names

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Epclusa® GS-7977/GS-5816 Sovaldi® GS-7977 PSI-7977

Eligibility Criteria

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Inclusion Criteria

* Willing and able to provide written informed consent
* HCV RNA ≥ 10\^4 IU/mL
* HCV genotype 2
* Chronic HCV infection (≥ 6 months)
* Females of childbearing potential must have a negative serum pregnancy test
* Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
* Must be of generally good health, with the exception of chronic HCV infection, as determined by the investigator.

Exclusion Criteria

* Current or prior history of clinically-significant illness (other than HCV that may interfere with treatment, assessment or compliance with the protocol;
* Screening electrocardiogram (ECG) with clinically significant abnormalities
* Laboratory results outside of acceptable ranges at Screening
* Pregnant or nursing female or male with pregnant female partner
* Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, alfa-1 antitrypsin deficiency, cholangitis)
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anu Osinusi, MD

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

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Long Beach, California, United States

Site Status