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AzTrials

Hepatitis C Virus InfectionPhase 3NCT02487030

Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination, With or Without Ribavirin, in Egyptian Adults With Chronic Genotype 4 HCV Infection

A Phase 3 study testing LDV/SOF and RBV in people with Hepatitis C Virus Infection, run by Gilead Sciences at 4 sites in Egypt.

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 objective of this study was to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) with or without ribavirin (RBV) in Egyptian adults with chronic genotype 4 hepatitis C virus (HCV) infection. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C Virus Infection
What is being tested?
LDV/SOF and RBV
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
255 participants
Where
4 sitesEgypt
Study dates
7 Sep 2015to 4 Feb 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 18 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
  • Chronic HCV infection (≥ 6 months) documented by medical history or liver biopsy
  • HCV genotype 4 at screening
  • HCV treatment naive or prior participation in this study or study GS-US-334-0138 (Cohorts 1 and 2 only)
  • Cohort 3 only: HCV treatment-experienced (previously received therapy for HCV infection with an interferon (IFN)-containing regimen, with or without RBV and/or an HCV NS3/NS4A protease inhibitor (PI)
  • Body mass index (BMI) ≥ 18 kg/m^2
  • Screening laboratory values within defined thresholds
  • Use of effective protocol-approved contraception methods

Who cannot join

  • History of clinically-significant illness or any other major medical disorder that may interfere with treatment, assessment or compliance with the protocol
  • Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
  • Pregnant or nursing females or male with pregnant female partner
  • Clinically-relevant drug or alcohol abuse within 12 months of screening
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

4 sites in 1 country.

Egypt4 sites

  • Study site

    Al Mansurah

  • Study site

    Cairo, 11559

  • Study site

    Cairo, 11796

  • Study site

    Shibīn al Kawm

Other trials in Egypt

About this study

Official title: A Phase 3, Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination, With or Without Ribavirin, in Egyptian Adults With Chronic Genotype 4 HCV Infection

The primary objective of this study was to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) with or without ribavirin (RBV) in Egyptian adults with chronic genotype 4 hepatitis C virus (HCV) infection.

Being tested
LDV/SOF, RBV
Keywords
HCV genotype 4 (GT-4), HCV, Sustained Virologic Response, Direct Acting Antiviral, Combination Therapy, GS-7977, GS-5885, Ribavirin, Sofosbuvir, ledipasvir, Hepatitis C, Hepatitis C, Chronic, Liver Diseases, Virus Diseases, Antiviral Agents
Medical subject headings
Hepatitis C, Hepatitis C, Chronic, Liver Diseases, Virus Diseases

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

  • RBVDrug

    Tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Study groups in NCT02487030
Study groupRoleWhat they receive
LDV/SOF 8 wk TN (Cohort 1, Group 1)ExperimentalLDV/SOF for 8 weeks (treatment-naive (TN))
Receives: Drug: LDV/SOF
LDV/SOF+RBV 8 wk TN (Cohort 1, Group 2)ExperimentalLDV/SOF+RBV for 8 weeks (treatment-naive)
Receives: Drug: LDV/SOF; Drug: RBV
LDV/SOF 12 wk TN (Cohort 1, Group 3)ExperimentalLDV/SOF for 12 weeks (treatment-naive)
Receives: Drug: LDV/SOF
LDV/SOF+RBV 12 wk TN (Cohort 1, Group 4)ExperimentalLDV/SOF+RBV for 12 weeks (treatment-naive)
Receives: Drug: LDV/SOF; Drug: RBV
LDV/SOF+RBV 12 wk TE (Cohort 2)ExperimentalTreatment-experienced (TE) participants who completed treatment in Gilead sponsored study GS-US-334-0138 or in Cohort 1 of this study and did not achieve SVR12 will receive LDV/SOF+RBV for 12 weeks.
Receives: Drug: LDV/SOF; Drug: RBV
LDV/SOF 12 wk TE (Cohort 3, Group 1)ExperimentalLDV/SOF for 12 weeks (treatment-experienced)
Receives: Drug: LDV/SOF
LDV/SOF+RBV 12 wk TE (Cohort 3, Group 2)ExperimentalLDV/SOF+RBV for 12 weeks (treatment-experienced)
Receives: Drug: LDV/SOF; Drug: RBV

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) 12 weeks following the last dose of study drug.

    Measured: Posttreatment Week 12

  2. Percentage of Participants Who Discontinued LDV/SOF Drug Due to an Adverse Event (AE)

    Measured: 12 weeks

Secondary outcomes (2)

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

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

    Measured: Posttreatment Weeks 4 and 24

  2. Percentage of Participants With Overall Virologic Failure

    Virologic failure was defined as

    • On-treatment virologic failure
    • confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment (ie, breakthrough),
    • confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment (ie, rebound),
    • HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie, nonresponse)
    • Relapse
    • HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement

    Measured: Up to Posttreatment 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 posted1 Jul 2015 (estimated)
  2. Study start7 Sep 2015
  3. Primary completion11 Nov 2016
  4. Study completion4 Feb 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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
255 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02487030
Sponsor's protocol ID
GS-US-337-1643
Status last verified
Nov 2017
First submitted
27 Jun 2015
Last updated
16 Nov 2018
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 http://www.gilead.com/research/disclosure-and-transparency.

Publications

  • Shiha G, Waked I, Soliman R, Abdelrazek W, Hassany M, Fouad R, et al. Ledipasvir/sofosbuvir for 8 or 12 weeks with or without ribavirin in HCV genotype 4 patients in Egypt. [Abstract OP158]. Asian Pacific Association for the Study of the Liver (APASL); 2017 15-19 February; Shanghai, China

  • Shiha G, Esmat G, Hassany M, Soliman R, Elbasiony M, Fouad R, Elsharkawy A, Hammad R, Abdel-Razek W, Zakareya T, Kersey K, Massetto B, Osinusi A, Lu S, Brainard DM, McHutchison JG, Waked I, Doss W. Ledipasvir/sofosbuvir with or without ribavirin for 8 or 12 weeks for the treatment of HCV genotype 4 infection: results from a randomised phase III study in Egypt. Gut. 2019 Apr;68(4):721-728. doi: 10.1136/gutjnl-2017-315906. Epub 2018 Apr 17.

    PubMed 29666174

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LDV/SOF and RBV in people with Hepatitis C Virus Infection, run by Gilead Sciences at 4 sites in Egypt.

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 8 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 16 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Egypt. 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 14 Dec 2017). 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 NCT02487030, which also lists 2 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 16 Nov 2018.

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