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Chronic HCV InfectionPhase 3NCT02021656

Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Participants With Chronic Genotype 1 HCV Infection

A Phase 3 study testing LDV/SOF in people with Chronic HCV Infection, run by Gilead Sciences at 45 sites in 3 countries.

Completed

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

Official record
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Trial summary

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in treatment-naive and treatment-experienced participants with chronic genotype 1 hepatitis C virus (HCV) infection. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Chronic HCV Infection
What is being tested?
LDV/SOF
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
384 participants
Where
45 sitesin 3 countries
Study dates
10 Dec 2013to 29 Sep 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • Willing and able to provide written informed consent
  • HCV RNA ≥ 10^4 IU/mL at screening
  • HCV treatment-naive, as defined as no prior exposure to any interferon (IFN) or other approved or experimental HCV-specific direct-acting antiviral agent; OR HCV treatment-experienced with medical records that include sufficient detail of prior IFN-based treatment to allow for categorization of prior response as either intolerant, non-responder, or experienced viral breakthrough or relapse.
  • Genotype 1 HCV at screening
  • HCV infection documented by anti-HCV antibody test, genotyping test, or liver biopsy

Who cannot join

  • Pregnant or nursing female
  • Chronic liver disease of a non-HCV etiology
  • Current or prior history of any clinically-significant illness (other than HCV)
  • Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
  • NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Trial locations and contacts

45 sites in 3 countries.

45 sites in 3 countries

China18 sites

  • Study site

    Beijing, 100015

  • Study site

    Beijing, 100034

  • Study site

    Beijing, 100044

  • Study site

    Beijing, 100050

  • Study site

    Beijing, 100069

  • Study site

    Chongqing, 400010

  • Study site

    Guangdong, 510515

  • Study site

    Guangxi, 530021

  • Study site

    Hubei, 430030

  • Study site

    Hunan, 410011

  • Study site

    Jiangxi, 210029

  • Study site

    Jiangxi, 330006

  • Study site

    Jilin City, 130021

  • Study site

    Shandong, 250021

  • Study site

    Shanghai, 200025

  • Study site

    Shanghai, 200083

  • Study site

    Shijiazhuang, 050051

  • Study site

    Sichuan, 610041

Other trials in China

South Korea15 sites

  • Study site

    Ansan-si, Gyeonggi-do, 425-707

  • Study site

    Bucheon-si, Gyeonggi-do, 420-767

  • Study site

    Busan, 602-715

  • Study site

    Busan, 602-739

  • Study site

    Busan, 614-735

  • Study site

    Daegu, 700-721

  • Study site

    Incheon, Gyeonggi-do, 405-760

  • Study site

    Seongnam-si, Gyeonggi-do, 467-707

  • Study site

    Seoul, 110-744

  • Study site

    Seoul, 120-752

  • Study site

    Seoul, 135-720

  • Study site

    Seoul, 137-701

  • Study site

    Seoul, 138-736

  • Study site

    Seoul, 152-703

  • Study site

    Seoul, 735-710

Other trials in South Korea

Taiwan12 sites

  • Study site

    Changhua, 50006

  • Study site

    Kaohsiung City, 80708

  • Study site

    Kaohsiung City, 82445

  • Study site

    Kaohsiung City, 83301

  • Study site

    Keelung, 20401

  • Study site

    Taichung, 40447

  • Study site

    Tainan, 70457

  • Study site

    Tainan, 73657

  • Study site

    Taipei, 10048

  • Study site

    Taipei, 10449

  • Study site

    Taipei, 11217

  • Study site

    Taoyuan, 33305

Other trials in Taiwan

About this study

Official title: A Phase 3b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination in Treatment-Naïve and Treatment-Experienced Subjects With Chronic Genotype 1 HCV Infection

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in treatment-naive and treatment-experienced participants with chronic genotype 1 hepatitis C virus (HCV) infection.

Being tested
LDV/SOF

What participants receive

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

  • LDV/SOFDrug

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

    90/400 mg FDC tablet administered orally once daily without regard to food

Study groups in NCT02021656
Study groupRoleWhat they receive
LDV/SOFExperimentalTreatment-experienced and treatment-naive participants will receive LDV/SOF for 12 weeks.
Receives: Drug: LDV/SOF

What is being measured

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

  1. Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)

    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, < 25 IU/mL in Korea and Taiwan and < 15 IU/mL in China) 12 weeks following the last dose of study drug.

    Measured: Posttreatment Week 12

  2. Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event

    Measured: Up to 12 weeks

Secondary outcomes (4)

  1. Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

    SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.

    Measured: Posttreatment Weeks 4 and 24

  2. Percentage of Participants Experiencing Viral Breakthrough

    Viral breakthrough were defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) during treatment, but did not achieve a sustained virologic response (SVR).

    Measured: Up to 12 weeks

  3. Percentage of Participants Experiencing Viral Relapse

    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: Week 12 to Posttreatment Week 24

  4. HCV RNA and Change From Baseline in HCV RNA Through Week 12 for China Only

    Measured: Baseline; Week 12

Timeline

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

  1. First posted27 Dec 2013 (estimated)
  2. Study start10 Dec 2013
  3. Primary completion8 Jul 2017
  4. Study completion29 Sep 2017

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
384 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02021656
Sponsor's protocol ID
GS-US-337-0131
Status last verified
Jan 2019
First submitted
20 Dec 2013
Last updated
5 Mar 2020
Data monitoring committee
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.

Publications

  • Wei L, Xie Q, Hou JL, et al. Safety and Efficacy of Ledipasvir/Sofosbuvir in a Genotype 1 HCV Infected Chinese Population: Results from a Phase 3 Clinical Trial. Poster No. 1191, AASLD 2017.

  • Lim YS, Ahn SH, Lee KS, Paik SW, Lee YJ, Jeong SH, Kim JH, Yoon SK, Yim HJ, Tak WY, Han SY, Yang JC, Mo H, Garrison KL, Gao B, Knox SJ, Pang PS, Kim YJ, Byun KS, Kim YS, Heo J, Han KH. A phase IIIb study of ledipasvir/sofosbuvir fixed-dose combination tablet in treatment-naive and treatment-experienced Korean patients chronically infected with genotype 1 hepatitis C virus. Hepatol Int. 2016 Nov;10(6):947-955. doi: 10.1007/s12072-016-9726-5. Epub 2016 May 20.

    PubMed 27198664

  • Chuang WL, Chien RN, Peng CY, Chang TT, Lo GH, Sheen IS, Wang HY, Chen JJ, Yang JC, Knox SJ, Gao B, Garrison KL, Mo H, Pang PS, Hsu YC, Hu TH, Chu CJ, Kao JH. Ledipasvir/sofosbuvir fixed-dose combination tablet in Taiwanese patients with chronic genotype 1 hepatitis C virus. J Gastroenterol Hepatol. 2016 Jul;31(7):1323-9. doi: 10.1111/jgh.13305.

    PubMed 26841930

  • Wei L, Xie Q, Hou JL, et al. Safety and Efficacy of Ledipasvir/Sofosbuvir in a Genotype 1 HCV Infected Chinese Population: Results from a Phase 3 Clinical Trial., [Abstract 1191]. The Liver Meeting® 2017 - The 68th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD); 2017 20-24 October; Washington, D. C.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LDV/SOF in people with Chronic HCV Infection, run by Gilead Sciences at 45 sites in 3 countries.

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 5 inclusion and 5 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 5 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in China, South Korea, Taiwan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) (time frame: Posttreatment 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 NCT02021656, which also lists 4 linked publications.

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 5 Mar 2020.

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