SOF/VEL±RBV: Efficacy and Safety in GT 3 and 6 HCV Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-08

Study Completion Date

2021-12-30

Brief Summary

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150 GT3 or GT6 CHC patients with or without compensated cirrhosis will be recruited from five centers in China including G3a 50, G3b 50, G6 50 respectively. GT3a and GT6 CHC with or without compensated patients will be administered one pill of Epclusa each day for 12 weeks, and GT3b patients will be administered Epclusa each plus Ribavirin for 12 weeks.

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Detailed Description

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This is a Prospective, observational, multi-center, real-world study to investigate real world effectiveness and safety of SOF/VEL±RBV in Chinese patients infected by HCV GT-3 and 6. 150 GT3 or GT6 CHC patients with or without compensated cirrhosis will be recruited from five centers in China including G3a 50, G3b 50, G6 50 respectively. GT3a and GT6 CHC with or without compensated cirrhosis will be administered one pill of Epclusa each day for 12 weeks, and GT3b patients will be administered one pill of Epclusa each plus Ribavirin for 12 weeks.Demographic, clinical, adverse event and virological data were be collected throughout treatment and post-treatment follow-up.

Conditions

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Hepatitis C

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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genotype 3a HCV

genotype 3a hepatitis C

Epclusa (sofosbuvir and velpatasvir)

Intervention Type DRUG

Epclusa (sofosbuvir and velpatasvir) is a nucleotide analog polymerase inhibitor and pan-genotypic NS5A inhibitor fixed-dose combination for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection.

genotype 6 HCV

genotype 6 hepatitis C

Epclusa (sofosbuvir and velpatasvir)

Intervention Type DRUG

Epclusa (sofosbuvir and velpatasvir) is a nucleotide analog polymerase inhibitor and pan-genotypic NS5A inhibitor fixed-dose combination for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection.

genotype 3b HCV

genotype 3b hepatitis C

Epclusa (sofosbuvir and velpatasvir)

Intervention Type DRUG

Epclusa (sofosbuvir and velpatasvir) is a nucleotide analog polymerase inhibitor and pan-genotypic NS5A inhibitor fixed-dose combination for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection.

Interventions

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Epclusa (sofosbuvir and velpatasvir)

Epclusa (sofosbuvir and velpatasvir) is a nucleotide analog polymerase inhibitor and pan-genotypic NS5A inhibitor fixed-dose combination for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* HCV RNA ≥ 15 IU/Ml at Screening
* HCV genotype 3a ,3b and 6
* Hepatitis C without decompensated cirrhosis of the liver

Exclusion Criteria

* Patients failed to previous NS5A-containing DAAs therapy
* Decompensated cirrhosis
* HCC
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No