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AzTrials

Chronic HCV InfectionPhase 2NCT02120300

Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination and Sofosbuvir + Ribavirin for Subjects With Chronic Hepatitis C Virus (HCV) and Inherited Bleeding Disorders

A Phase 2 study testing LDV/SOF, SOF and RBV in people with Chronic HCV Infection, run by Gilead Sciences at 13 sites in United States.

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 antiviral efficacy, safety, and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in participants with genotypes 1 and 4 hepatitis C virus (HCV) infection and sofosbuvir (SOF) plus ribavirin (RBV) in participants with… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic HCV Infection
What is being tested?
LDV/SOF, SOF and RBV
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
122 participants
Where
13 sitesUnited States
Study dates
Apr 2014to Aug 2015
Phase
Phase 2
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

  • Hemophilia A, B or C, or Von Willebrand's disease
  • Chronic genotype 1, 2, 3 or 4 HCV infection
  • HCV RNA ≥ 1000 IU/mL at screening
  • Use of protocol specified method(s) of contraception if female of childbearing potential or sexually active male
  • Screening laboratory values within defined thresholds
  • For HIV-1/HCV co-infected individuals:
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  • Suppressed HIV-1 RNA on an antiretroviral (ARV) regimen for at least 6 months prior to screening
  • Stable protocol-approved ARV regimen for > 8 weeks prior to screening
  • CD4 T-cell count > 200 cells/mm^3 at screening

Who cannot join

  • Clinically-significant illness (other than HCV, inherited bleeding disorder or HIV-1) or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
  • Current or prior history of any of the following:
  • Hepatic decompensation
  • Chronic liver disease of a non-HCV etiology
  • Hepatocellular carcinoma (HCC)
  • Infection with hepatitis B virus (HBV)
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  • Pregnant or nursing female
  • Prior treatment with inhibitors of nonstructural protein 5A (NS5A) or the NS5B polymerase
  • Chronic use of systemically administered immunosuppressive agents
  • For HIV-1/HCV co-infected individuals:
  • Opportunistic infection within 6 months prior to screening
  • Active, serious infection (other than HIV-1 or HCV) requiring parental antibiotics, antivirals or antifungals within 30 days prior to baseline

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • Study site

    Atlanta, Georgia, 30308

  • Study site

    Boston, Massachusetts, 02114

  • Study site

    Boston, Massachusetts, 02115

  • Study site

    Chapel Hill, North Carolina, 27599-7584

  • Study site

    Minneapolis, Minnesota, 55407

  • Study site

    New York, New York, 10029

  • Study site

    Newark, New Jersey, 07112

  • Study site

    Philadelphia, Pennsylvania, 19104

  • Study site

    Rochester, New York, 14621

  • Study site

    Sacramento, California, 95817

  • Study site

    San Diego, California, 92103-8651

  • Study site

    San Francisco, California, 94143

  • Study site

    Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Official title: A Phase 2b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination and Sofosbuvir + Ribavirin for Subjects With Chronic Hepatitis C Virus (HCV) and Inherited Bleeding Disorders

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in participants with genotypes 1 and 4 hepatitis C virus (HCV) infection and sofosbuvir (SOF) plus ribavirin (RBV) in participants with genotypes 2 and 3 HCV infection. Participants with an inherited bleeding disorder and chronic HCV infection (either monoinfected or HIV-1/HCV coinfected) will be enrolled.

Being tested
LDV/SOF, SOF, RBV

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

  • SOFDrug

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

    400 mg tablet administered orally once daily

  • RBVDrug

    Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Study groups in NCT02120300
Study groupRoleWhat they receive
LDV/SOF GT 1 or 4ExperimentalParticipants with chronic genotypes (GT) 1 or 4 HCV infection will receive LDV/SOF for 12 or 24 weeks. Treatment-experienced cirrhotic participants with genotype 1 HCV infection will receive LDV/SOF for 24 weeks.
Receives: Drug: LDV/SOF
SOF+RBV 12 wks GT 2ExperimentalParticipants with chronic genotype 2 HCV infection will receive SOF+RBV for 12 weeks.
Receives: Drug: SOF; Drug: RBV
SOF+RBV 24 wks GT 3ExperimentalParticipants with chronic genotype 3 HCV infection will receive SOF+RBV for 24 weeks.
Receives: Drug: 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 (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)

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

    Measured: Posttreatment Week 12

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

    Measured: Up to 24 weeks

Secondary outcomes (6)

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

    SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.

    Measured: Posttreatment Week 4

  2. Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24

    Measured: Weeks 1, 2, 4, 8, 12, 16, 20, and 24

  3. Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24

    Measured: Baseline; Weeks 1, 2, 4, 8, 12, 16, 20, and 24

  4. Percentage of Participants With Virologic Failure

    Virologic failure was defined as:

    • On-treatment virologic failure:
    • Breakthrough (confirmed HCV RNA ≥ LLOQ 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)
    • Virologic relapse:
    • Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.

    Measured: Up to Posttreatment Week 24

  5. Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL at Weeks 4, 8, 12, 16, 20, and 24 (HIV-1/HCV Co-infected Participants Only)

    Measured: Weeks 4, 8, 12, 16, 20, and 24

  6. Change From Baseline in Serum Creatinine at the End of Treatment and at Posttreatment Week 12 (HIV-1/HCV Co-infected Participants Only)

    Measured: Baseline; Weeks 12, 24, and Posttreatment 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 posted22 Apr 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionAug 2015
  4. Study completionAug 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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
122 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02120300
Sponsor's protocol ID
GS-US-334-1274
Status last verified
Oct 2016
First submitted
18 Apr 2014
Last updated
6 Dec 2016
Data monitoring committee
No

Publications

  • Walsh C, Workowski K, Terrault N, Sax S, Cohen A, et al. Approved All-Oral Sofosbuvir Regimens Are Safe and Highly Effective in Patients With Hereditary Bleeding Disorders. (2015). Hepatology, 62 (S1): 714A-807A. doi:10.1002/hep.28228

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LDV/SOF, SOF and RBV in people with Chronic HCV Infection, run by Gilead Sciences at 13 sites in United States.

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 9 inclusion and 12 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 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. 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?

Yes. Results are posted in the registry (first posted 6 Dec 2016). 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 NCT02120300, 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 6 Dec 2016.

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