NCT02576314

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 genotype 3 infection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2015

Typical duration for phase_3

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

May 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 15, 2015

Completed
2.2 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

2.7 years

First QC Date

October 12, 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 (SVR12) after discontinuation of therapy

    SVR12 is defined as HCV RNA \< the lower limit of quantitation (LLOQ \< 25 IU/mL) 12 weeks following the last dose of study medication

    Post treatment Week 12

  • Incidence of adverse events leading to permanent discontinuation of study drug

    Baseline up to Week 12

Secondary Outcomes (4)

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

    Baseline up to Week 12

  • HCV RNA levels and change during and after treatment

    Baseline up to Week 12

  • Treatment adherence

    Baseline to Week 12

  • Change in health related quality of life

    Baseline to Week 24

Study Arms (2)

Sofosbuvir and Daclatasvir

ACTIVE COMPARATOR

Participants will receive Sofosbuvir (SOF) 400 mg and Daclatasvir (DCV) 60 mg daily for 12 weeks.

Drug: sofosbuvir and daclatasvir

Ledipasvir/sofosbuvir

ACTIVE COMPARATOR

Participants will receive Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet daily for 12 weeks.

Drug: ledipasvir/sofosbuvir

Interventions

sofosbuvir and daclatasvirDRUG

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

Also known as: Sovaldi®, PSI-7977, GS-7977, Daklinza®, BMS-790052
Sofosbuvir and Daclatasvir
ledipasvir/sofosbuvirDRUG

Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally. once daily;

Also known as: Harvoni®, GS-5885, GS-7977, PSI-7977
Ledipasvir/sofosbuvir

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 3 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;
  • Negative pregnancy test at baseline (females of childbearing potential only);
  • Use of two effective contraception methods if female of childbearing potential or sexually active male.

You may not qualify if:

  • Pregnant or nursing female;
  • HIV infection or HBV infection (HBcAb and HBsAg positive);
  • 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

Sofosbuvirdaclatasvirledipasvir, sofosbuvir drug combinationledipasvir

Intervention Hierarchy (Ancestors)

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

Study Officials

  • George Lau, MD

    Humanity and Health GI and Liver Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2015

First Posted

October 15, 2015

Study Start

May 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)