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Hepatitis C Virus InfectionPhase 3NCT02613871

Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Chronic HCV and HBV Coinfection

A Phase 3 study testing LDV/SOF in people with Hepatitis C Virus Infection, run by Gilead Sciences at 8 sites in Taiwan.

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 determine the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with chronic genotype 1 or 2 HCV infection who are coinfected with HBV in Taiwan. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Hepatitis C Virus 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
111 participants
Where
8 sitesTaiwan
Study dates
22 Dec 2015to 7 Nov 2018
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

  • Individuals ≥ 40 kg in weight with chronic genotype 1 or 2 HCV and HBV coinfection
  • Individuals must not be taking or requiring treatment with HBV antiviral therapy at screening. For participants that are HBV treatment experienced, the most recent treatment must have been completed at least 6 months prior to Day 1.
  • Cirrhosis determination by Fibroscan
  • Screening laboratory values within defined thresholds
  • Use of two effective contraception methods if female or male is of childbearing potential

Who cannot join

  • Current or prior history of clinically-significant illness or any other major medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol
  • Pregnant or nursing female
  • Infection with human immunodeficiency virus (HIV) or hepatitis delta virus (HDV)
  • Hepatocellular carcinoma (HCC) or other malignancy
  • Current or prior history of clinical hepatic decompensation
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Taiwan8 sites

  • Study site

    Changhua

  • Study site

    Chiayi City

  • Study site

    Kaohsiung City

  • Study site

    Keelung

  • Study site

    Taichung

  • Study site

    Tainan

  • Study site

    Taipei

  • Study site

    Taoyuan

Other trials in Taiwan

About this study

Official title: A Phase 3b Open-Label Study of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 2 Hepatitis C Virus (HCV) and Hepatitis B Virus (HBV) Coinfection

The primary objectives of this study are to determine the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with chronic genotype 1 or 2 HCV infection who are coinfected with HBV in Taiwan.

Being tested
LDV/SOF
Medical subject headings
Hepatitis C

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

Study groups in NCT02613871
Study groupRoleWhat they receive
LDV/SOFExperimentalLDV/SOF FDC 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 (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)

    SVR12 was defined as HCV RNA < the lower limit of quantification (LLOQ; 15 IU/mL) at 12 weeks after stopping study treatment.

    Measured: Posttreatment Week 12

  2. Percentage of Participants With Any Adverse Event Leading to Permanent Discontinuation of Study Drug

    Measured: First dose date up to 12 weeks

Secondary outcomes (14)

  1. Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)

    SVR4 was defined as HCV RNA < LLOQ (15 IU/mL) at 4 weeks after stopping study treatment.

    Measured: Posttreatment Week 4

  2. Percentage of Participants With HCV RNA < LLOQ While on Treatment

    LLOQ = 15 IU/mL

    Measured: Weeks 1, 2, 4, 8, and 12

  3. Percentage of Participants With HCV RNA < LLOQ at Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108

    LLOQ = 15 IU/mL

    Measured: Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108

  4. HCV RNA Change From Baseline While on Treatment

    Measured: Weeks 1, 2, 4, 8, and 12

  5. Percentage of Participants With Virologic Failure

    Virologic failure was defined as :

    • Breakthrough (confirmed HCV RNA ≥ LLOQ [15 IU/mL] after having previously had HCV RNA < LLOQ while on treatment), or
    • Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
    • Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment), or
    • Relapse (HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement)

    Measured: First dose date up to Posttreatment Week 12

  6. Plasma HBV DNA Change From Baseline While on Treatment

    Measured: Weeks 1, 2, 4, 8, and 12

  7. Plasma HBV DNA Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108

    Measured: Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108

  8. HBsAg Level Change From Baseline While on Treatment

    Measured: Weeks 1, 2, 4, 8, and 12

  9. HBsAg Level Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108

    Measured: Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108

  10. Serum LOXL-2 Level Change From Baseline While on Treatment

    Measured: Weeks 1, 2, 4, 8, and 12

  11. Serum LOXL-2 Level Change From Baseline at Posttreatment Weeks 4, 12, and 36

    Measured: Posttreatment Weeks 4, 12, and 36

  12. Percentage of Participants That Required HBV Therapy During the Study

    Measured: First dose date up to Posttreatment Week 108

  13. Fibrosis Status as Assessed by Fibroscan Score at Posttreatment Weeks 12, 60, and 108

    FibroScan is a non-invasive device that assesses the hardness (or stiffness) of the liver using the technique of transient elastography. FibroScan results range from 2.5 kPa to 75 kPa with higher scores indicating greater liver stiffness. Per protocol, cirrhosis status was determined as follows:

    • Presence of cirrhosis = FibroScan result of > 12.5 kPa
    • Absence of cirrhosis = FibroScan result of ≤ 12.5 kPa

    Measured: Posttreatment Weeks 12, 60, and 108

  14. Percentage of Participants That Develop Hepatocellular Carcinoma (HCC) During the Study

    Measured: First dose date up to Posttreatment Week 108

Timeline

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

  1. First posted25 Nov 2015 (estimated)
  2. Study start22 Dec 2015
  3. Primary completion4 Jan 2017
  4. Study completion7 Nov 2018

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
111 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02613871
Sponsor's protocol ID
GS-US-337-1655
Status last verified
Nov 2019
First submitted
23 Nov 2015
Last updated
6 Mar 2020
Data monitoring committee
No
FDA-regulated drug
Yes
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

  • Liu CJ, Chuang WL, Sheen IS, Wang HY, Chen CY, Tseng KC, et al. Ledipasvir/Sofosbuvir for 12 Weeks Is Safe and Effective in Patients With Chronic Hepatitis C and Hepatitis B Coinfection: a Phase 3 Study in Taiwan [Poster SAT-243]. EASL: The International Liver Congress; 2019 10-14 April; Vienna, Austria.

  • Liu CJ, Chuang WL, Sheen IS, Wang HY, Chen CY, Tseng KC, et al. Declines in HBsAg Levels Observed During Treatment With Ledispavir/Sofosbuvir in Patients With Chronic Hepatitis B Virus and Hepatitis C Virus Infection [Poster 1083]. 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.

  • Liu CJ, Chuang WL, Sheen IS, Wang HY, Chen CY, Tseng KC, Chang TT, Massetto B, Yang JC, Yun C, Knox SJ, Osinusi A, Camus G, Jiang D, Brainard DM, McHutchison JG, Hu TH, Hsu YC, Lo GH, Chu CJ, Chen JJ, Peng CY, Chien RN, Chen PJ. Efficacy of Ledipasvir and Sofosbuvir Treatment of HCV Infection in Patients Coinfected With HBV. Gastroenterology. 2018 Mar;154(4):989-997. doi: 10.1053/j.gastro.2017.11.011. Epub 2017 Nov 22.

    PubMed 29174546

  • Liu CJ, Chuang WL, Sheen IS, Wang HY, Chen CY, Tseng KC, et al. Ledipasvir/Sofosbuvir for 12 Weeks Is Safe and Effective in Patients with Chronic Hepatitis C and Hepatitis B Coinfection: A Phase 3 Study in Taiwan [Presentation]. The International Liver Congress™ 2017: European Association for the Study of the Liver (EASL); 2017 19-23 April; Amsterdam, the Netherlands.

  • Liu CJ, Sheen IS, Chen CY, Chuang WL, Wang HY, Tseng KC, Chang TT, Yang J, Massetto B, Suri V, Camus G, Jiang D, Zhang F, Gaggar A, Hu TH, Hsu YC, Lo GH, Chu CJ, Chen JJ, Peng CY, Chien RN, Chen PJ. Ledipasvir/Sofosbuvir for Patients Coinfected With Chronic Hepatitis C and Hepatitis B in Taiwan: Follow-up at 108 Weeks Posttreatment. Clin Infect Dis. 2022 Aug 31;75(3):453-459. doi: 10.1093/cid/ciab971.

    PubMed 34864948

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LDV/SOF in people with Hepatitis C Virus Infection, run by Gilead Sciences at 8 sites in Taiwan.

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 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 6 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 8 sites in 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 13 Feb 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 (SVR) 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 NCT02613871, which also lists 5 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 6 Mar 2020.

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