AzTrials
AzTrials

Chronic Hepatitis C InfectionPhase 2NCT02470858

Triple DAAs Regimen in Treating Non-cirrhotic HCV GT1b Subjects

A Phase 2 study testing LDV/SOF+ASV, SOF+DCV+SMV and SOF+DCV+ASV in people with Chronic Hepatitis C Infection, run by Humanity and Health Research Centre at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The study is designed to test the hypothesis that the addition of a protease inhibitor to dual NS5a-NS5B nucleoside prodrug analog will enhance antiviral efficacy and hence shorten the treatment duration to 3 weeks. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Hepatitis C Infection
What is being tested?
LDV/SOF+ASV, SOF+DCV+SMV and SOF+DCV+ASV
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteChina
Study dates
Jan 2015to Dec 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age equal to or greater than 18 years, with chronic genotype 1b HCV infection;
  • HCV RNA level > 10,000 and < 10,000,000 IU/ml at Screening;
  • Rapid response to triple DAAs therapy with less than 500 IU/ml plasma HCV RNA level at Day 2;
  • No evidence of cirrhosis. Cirrhosis defined as any 1 of the following, within 6 months of study entry:
  • Liver biopsy showing cirrhosis;
  • Fibroscan showing cirrhosis or results>12.5 kPa ;
  • FibroTest® score >0.75 and an aspartate aminotransferase (AST): platelet ratio index (APRI) >2 during screening.

Who cannot join

  • 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);
  • History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Humanity and Health GI and Liver Centre

    Hong Kong, Hong Kong, 00852

Other trials in China

About this study

Official title: Effect of Triple Direct Acting Antiviral Agents (DAAs) for Non-cirrhotic Subjects With Chronic HCV G1b Infection

The study is designed to test the hypothesis that the addition of a protease inhibitor to dual NS5a-NS5B nucleoside prodrug analog will enhance antiviral efficacy and hence shorten the treatment duration to 3 weeks.

Being tested
LDV/SOF+ASV, SOF+DCV+SMV, SOF+DCV+ASV

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LDV/SOF+ASVDrug

    Also called GS-7977, PSI-7977, GS-5885, Harvoni®

    Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed-dose combination (FDC) tablet; administered orally once daily; Asunaprevir (ASV) 200mg, administered orally twice daily.

  • SOF+DCV+SMVDrug

    Also called GS-7977, PSI-7977, Sovaldi®, BMS-790052

    Sofosbuvir (SOF) 400 mg tablet administered orally once daily; Daclatasvir (DCV) 60 mg tablet administered orally once daily; Simeprevir (SMV) 150 mg tablet orally once daily.

  • SOF+DCV+ASVDrug

    Also called GS-7977, PSI-7977, Sovaldi®, BMS-790052

    Sofosbuvir (SOF) 400 mg tablet administered orally once daily; Daclatasvir (DCV) 60 mg tablet administered orally once daily; Asunaprevir (ASV) 200mg, administered orally twice daily.

Study groups in NCT02470858
Study groupRoleWhat they receive
LDV/SOF+ASVExperimentalParticipants with genotype 1b HCV infection will receive LDV/SOF FDC + ASV 3 weeks.
Receives: Drug: LDV/SOF+ASV
SOF+DCV+SMVExperimentalParticipants with genotype 1b HCV infection will receive SOF + DCV + SMV for 3 weeks.
Receives: Drug: SOF+DCV+SMV
SOF+DCV+ASVExperimentalParticipants with genotype 1b HCV infection will receive SOF + DCV + ASV for 3 weeks
Receives: Drug: SOF+DCV+ASV

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy (SVR12)

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

    Measured: Post treatment Week 12

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

    Measured: Baseline up to Week 24

Secondary outcomes (3)

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

    Measured: Baseline up to Week 24

  2. HCV RNA levels and change during and after treatment.

    Measured: Baseline up to Week 24

  3. Proportion of participants with on-treatment virologic breakthrough and relapse

    Viral breakthrough is defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) during treatment, but did not achieve a sustained virologic response (SVR). Viral relapse is defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) within 4 weeks of end of treatment, but did not achieve an SVR.

    Measured: Baseline up to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2015 (estimated)
  2. Study startJan 2015
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02470858
Sponsor's protocol ID
H&H_Triple Therapy_1
Status last verified
Feb 2016
First submitted
5 Jun 2015
Last updated
1 Mar 2016
Results posted
No
Data monitoring committee
No

Publications

  • Lau G, Benhamou Y, Chen G, Li J, Shao Q, Ji D, Li F, Li B, Liu J, Hou J, Sun J, Wang C, Chen J, Wu V, Wong A, Wong CL, Tsang ST, Wang Y, Bassit L, Tao S, Jiang Y, Hsiao HM, Ke R, Perelson AS, Schinazi RF. Efficacy and safety of 3-week response-guided triple direct-acting antiviral therapy for chronic hepatitis C infection: a phase 2, open-label, proof-of-concept study. Lancet Gastroenterol Hepatol. 2016 Oct;1(2):97-104. doi: 10.1016/S2468-1253(16)30015-2. Epub 2016 Jul 25.

    PubMed 27917405

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LDV/SOF+ASV, SOF+DCV+SMV and SOF+DCV+ASV in people with Chronic Hepatitis C Infection, run by Humanity and Health Research Centre at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy (SVR12) (time frame: Post treatment Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02470858, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2016; AzTrials last refreshed its copy on 7 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in