NCT02482077

Brief Summary

The purpose of this study is to assess the safety, tolerability, and efficacy of Sofosbuvir containing regimens in treatment-naive or treatment-experienced patients with HCV genotypes 2 infection.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2015

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 25, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2018

Completed
Last Updated

March 19, 2018

Status Verified

March 1, 2018

Enrollment Period

3 years

First QC Date

June 23, 2015

Last Update Submit

March 16, 2018

Conditions

Chronic Hepatitis C Infection

Outcome Measures

Primary Outcomes (2)

  • Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy

    SVR12 is defined as HCV RNA \< lower limit of quantification (LLOQ) 12 weeks after last dose of study drug.

    Post treatment Week 12

  • Proportion of participants with adverse events leading to permanent discontinuation of study drug(s)

    Baseline up to Week 24

Secondary Outcomes (3)

  • Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment

    Baseline up to Week 24

  • HCV RNA levels and change during and after treatment.

    Baseline up to Week 24

  • Proportion of participants with on-treatment virologic breakthrough and relapse

    Baseline up to Week 24

Study Arms (6)

SOF+RBV 8 wk

EXPERIMENTAL

Participants will receive SOF+RBV for 8 weeks.

Drug: SOF+RBV

SOF+RBV 12 wk

EXPERIMENTAL

Participants will receive SOF+RBV for 12 weeks.

Drug: SOF+RBV

SOF+DCV 8 wk

EXPERIMENTAL

Participants will receive SOF+DCV for 8 weeks.

Drug: SOF+DCV

SOF+DCV 12 wk

EXPERIMENTAL

Participants will receive SOF+DCV for 12 weeks.

Drug: SOF+DCV

LDV/SOF 8 wk

EXPERIMENTAL

Participants will receive LDV/SOF for 8 weeks.

Drug: LDV/SOF

LDV/SOF 12 wk

EXPERIMENTAL

Participants will receive LDV/SOF for 12 weeks.

Drug: LDV/SOF

Interventions

SOF+RBVDRUG

Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).

Also known as: GS-7977, PSI-7977, Sovaldi®, Copegus®
SOF+RBV 12 wkSOF+RBV 8 wk
SOF+DCVDRUG

Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Daclatasvir (DCV) 60mg tablet administered once daily.

Also known as: GS-7977, PSI-7977, Sovaldi®, BMS-790052, Daklinza®
SOF+DCV 12 wkSOF+DCV 8 wk
LDV/SOFDRUG

Ledipasvir 90 mg /Sofosbuvir 400 mg (LDV/SOF) FDC tablet administered orally once daily

Also known as: GS-7977/GS-5885, Harvoni®
LDV/SOF 12 wkLDV/SOF 8 wk

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age equal to or greater than 18 years, with chronic genotype 2 HCV infection;
  • Documented HCV treatment-naïve or treatment-experienced subjects who failed previous PEG+RBV regimen;
  • HCV RNA \> 10,000 IU/mL at Screening;
  • Screening laboratory values within defined thresholds
  • Use of two effective contraception methods if female of childbearing potential or sexually active male

You may not qualify if:

  • Pregnant or nursing female or male with pregnant female partner;
  • HIV or chronic hepatitis B virus (HBV) infection;
  • Hematologic or biochemical parameters at Screening outside the protocol-specified requirements;
  • Active or recent history (≤ 1 year) of drug or alcohol abuse;
  • Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital

Beijing, Beijing Municipality, 100039, China

Location

Humanity and Health GI and Liver Centre

Hong Kong, Hong Kong, 00852, China

Location

MeSH Terms

Interventions

SofosbuvirRibavirindaclatasvirledipasvir, sofosbuvir drug combination

Intervention Hierarchy (Ancestors)

Uridine MonophosphateUracil NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotidesRibonucleosidesNucleosides

Study Officials

  • George KK Lau, MD

    Humanity and Health GI and Liver Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2015

First Posted

June 25, 2015

Study Start

January 1, 2015

Primary Completion

December 31, 2017

Study Completion

March 15, 2018

Last Updated

March 19, 2018

Record last verified: 2018-03

Locations

CN(2)