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Chronic HCV InfectionPhase 2NCT01938430

Ledipasvir/Sofosbuvir Fixed-Dose Combination + Ribavirin in Subjects With Chronic HCV With Advanced Liver Disease or Post-Liver Transplant

A Phase 2 study testing LDV/SOF and RBV in people with Chronic HCV Infection, run by Gilead Sciences at 30 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

This study will evaluate ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) in participants with advanced liver disease or posttransplant and chronic genotype 1 or 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
Chronic HCV 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
339 participants
Where
30 sitesUnited States
Study dates
Sep 2013to Mar 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

  • Able to provide written informed consent
  • Chronic genotype 1 or 4 HCV infection
  • Normal ECG
  • Negative serum pregnancy test for female subjects
  • Male subjects and female subjects of childbearing potential must agree to use contraception
  • Able to comply with the dosing instructions for study drug and able to complete the study schedule of assessments, including all required post treatment visits

Who cannot join

  • Serious or active medical or psychiatric illness
  • HIV or hepatitis B viral (HBV) infection
  • Stomach disorder that could interfere with the absorption of the study drug
  • Treated with an anti-HCV medication in the last 30 days
  • Any prior exposure to an HCV nonstructural protein (NS)5a-specific inhibitor
  • Use of human granulocyte-macrophage colony-stimulating factor (GM-CSF), epoetin alfa or other therapeutic hematopoietic agents within 2 weeks of screening
Show all 13Show fewer
  • History of clinically significant medical condition associated with other chronic liver disease
  • Active spontaneous bacterial peritonitis at screening
  • Females who are breastfeeding
  • Infection requiring systemic antibiotics
  • Participated in a clinical study with an investigational drug or biologic within the last 30 days
  • Active or history (last 6 months) of drug or alcohol abuse
  • History of organ transplant other than liver or kidney

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

United States30 sites

  • Study site

    Ann Arbor, Michigan, 48109

  • Study site

    Aurora, Colorado, 80045

  • Study site

    Boston, Massachusetts, 02215

  • Study site

    Chapel Hill, North Carolina, 27599

  • Study site

    Chicago, Illinois, 60611

  • Study site

    Cleveland, Ohio, 44195

  • Study site

    Dallas, Texas, 75246

  • Study site

    Detroit, Michigan, 48202

  • Study site

    Durham, North Carolina, 27710

  • Study site

    Indianapolis, Indiana, 46202

  • Study site

    Jacksonville, Florida, 32224

  • Study site

    Kansas City, Kansas, 66160

  • Study site

    Lutherville, Maryland, 21093

  • Study site

    Miami, Florida, 33136

  • Study site

    Minneapolis, Minnesota, 55455

  • Study site

    Murray, Utah, 84107

  • Study site

    New York, New York, 10016

  • Study site

    New York, New York, 10032

  • Study site

    Philadelphia, Pennsylvania, 19104

  • Study site

    Phoenix, Arizona, 85054

  • Study site

    Pittsburgh, Pennsylvania, 15213

  • Study site

    Portland, Oregon, 97239

  • Study site

    Richmond, Virginia, 23219

  • Study site

    Rochester, Minnesota, 55905

  • Study site

    San Diego, California, 92103

  • Study site

    San Francisco, California, 94143

  • Study site

    Seattle, Washington, 98101

  • Study site

    Seattle, Washington, 98104

  • Study site

    St Louis, Missouri, 63110

  • Study site

    Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Official title: A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Ledipasvir Fixed-Dose Combination + Ribavirin Administered in Subjects Infected With Chronic HCV Who Have Advanced Liver Disease or Are Post-Liver Transplant

This study will evaluate ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) in participants with advanced liver disease or posttransplant and chronic genotype 1 or 4 hepatitis C virus (HCV) infection.

  • Cohort A: decompensated cirrhosis (advanced liver disease), no prior liver transplant;
  • Cohort B: post-liver transplant, with or without cirrhosis;
  • Group assignment within cohorts is based on severity of liver impairment at screening (Child-Pugh-Turcotte (CPT) score for participants with cirrhosis; fibrosis; or presence of disease for fibrosing cholestatic hepatitis (FCH) groups)
  • Randomization is 1:1 within groups to 12 or 24 weeks of LDV/SOF+RBV treatment.
Being tested
LDV/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

    LDV/SOF FDC tablet administered orally once daily

  • RBVDrug

    RBV tablets administered orally in a divided daily dose

Study groups in NCT01938430
Study groupRoleWhat they receive
Cohort A, Group 1 (12 wk): CPT Class B (7-9)ExperimentalLDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
Receives: Drug: LDV/SOF; Drug: RBV
Cohort A, Group 1 (24 wk): CPT Class B (7-9)ExperimentalLDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
Receives: Drug: LDV/SOF; Drug: RBV
Cohort A, Group 2 (12 wk): CPT Class C (10-12)ExperimentalLDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
Receives: Drug: LDV/SOF; Drug: RBV
Cohort A, Group 2 (24 wk): CPT Class C (10-12)ExperimentalLDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
Receives: Drug: LDV/SOF; Drug: RBV
Cohort B, Group 3 (12 wk): F0-F3 FibrosisExperimentalLDV/SOF (90/400 mg) plus RBV (weight-based: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
Receives: Drug: LDV/SOF; Drug: RBV
Cohort B, Group 3 (24 wk): F0-F3 FibrosisExperimentalLDV/SOF (90/400 mg) plus RBV (weight-based: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
Receives: Drug: LDV/SOF; Drug: RBV
Cohort B, Group 4 (12 wk): CPT Class A (5-6)ExperimentalLDV/SOF (90/400 mg) plus RBV (weight-based: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
Receives: Drug: LDV/SOF; Drug: RBV
Cohort B, Group 4 (24 wk): CPT Class A (5-6)ExperimentalLDV/SOF (90/400 mg) plus RBV (weight-based: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
Receives: Drug: LDV/SOF; Drug: RBV
Cohort B, Group 5 (12 wk): CPT Class B (7-9)ExperimentalLDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
Receives: Drug: LDV/SOF; Drug: RBV
Cohort B, Group 5 (24 wk): CPT Class B (7-9)ExperimentalLDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
Receives: Drug: LDV/SOF; Drug: RBV
Cohort B, Group 6 (12 wk): CPT Class C (10-12)ExperimentalLDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
Receives: Drug: LDV/SOF; Drug: RBV
Cohort B, Group 6 (24 wk): CPT Class C (10-12)ExperimentalLDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
Receives: Drug: LDV/SOF; Drug: RBV
Cohort B, Group 7 (12 wk): FCHExperimentalLDV/SOF (90/400 mg) plus RBV (weight-based: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
Receives: Drug: LDV/SOF; Drug: RBV
Cohort B, Group 7 (24 wk): FCHExperimentalLDV/SOF (90/400 mg) plus RBV (weight-based: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
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 (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 Discontinued Study Drug Due to an Adverse Event

    Measured: Up to 24 weeks

Secondary outcomes (23)

  1. Percentage of Participants With SVR 2 Weeks After Discontinuation of Therapy (SVR2)

    SVR2 was defined as HCV RNA < LLOQ at 2 weeks after stopping study treatment.

    Measured: Posttreatment Week 2

  2. Percentage of Participants With SVR 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

  3. Percentage of Participants With SVR 8 Weeks After Discontinuation of Therapy (SVR8)

    SVR8 was defined as HCV RNA < LLOQ at 8 weeks after stopping study treatment.

    Measured: Posttreatment Week 8

  4. Percentage of Participants With SVR 24 Weeks After Discontinuation of Therapy (SVR24)

    SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.

    Measured: Posttreatment Week 24

  5. 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 on 2 consecutive measurements while on treatment), or
    • Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on 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

  6. Percentage of Participants With Posttransplant Virologic Response (pTVR) at Posttransplant Week 12

    pTVR was defined as HCV RNA < LLOQ at Week 12 after transplant.

    Measured: Posttransplant Week 12

  7. Percentage of Participants With HCV RNA < LLOQ at Week 1

    Measured: Week 1

  8. Percentage of Participants With HCV RNA < LLOQ at Week 2

    Measured: Week 2

  9. Percentage of Participants With HCV RNA < LLOQ at Week 4

    Measured: Week 4

  10. Percentage of Participants With HCV RNA < LLOQ at Week 6

    Measured: Week 6

  11. Percentage of Participants With HCV RNA < LLOQ at Week 8

    Measured: Week 8

  12. Percentage of Participants With HCV RNA < LLOQ at Week 12

    Measured: Week 12

  13. Percentage of Participants With HCV RNA < LLOQ at Week 16

    Measured: Week 16

  14. Percentage of Participants With HCV RNA < LLOQ at Week 20

    Measured: Week 20

  15. Percentage of Participants With HCV RNA < LLOQ at Week 24

    Measured: Week 24

  16. HCV RNA and Change From Baseline at Week 1

    Measured: Baseline; Week 1

  17. HCV RNA and Change From Baseline at Week 2

    Measured: Baseline; Week 2

  18. HCV RNA and Change From Baseline at Week 4

    Measured: Baseline; Week 4

  19. HCV RNA and Change From Baseline at Week 6

    Measured: Baseline; Week 6

  20. HCV RNA and Change From Baseline at Week 8

    Measured: Baseline; Week 8

  21. HCV RNA and Change From Baseline at Week 12

    Measured: Baseline; Week 12

  22. Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score

    Model for End-Stage Liver Disease (MELD) scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40; higher scores/increased scores indicate greater severity of disease.

    Measured: Baseline to Posttreatment Week 4

  23. Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score

    CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for entry into the study was 12); higher scores/increased scores indicate greater severity of disease. Groups are arranged by cohort, then by duration of treatment, then by CPT class at baseline.

    Measured: Baseline to Posttreatment Week 4

Timeline

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

  1. First posted10 Sep 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionJan 2015
  4. Study completionMar 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
339 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01938430
Sponsor's protocol ID
GS-US-337-0123
Status last verified
Mar 2016
First submitted
5 Sep 2013
Last updated
16 Nov 2018
Data monitoring committee
Yes
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

  • Welzel TM, Reddy KR, Flamm SL, Denning J, Lin M, Hyland R, Pang PS, McHutchison JG, Charlton M, Everson GT, Zeuzem S, Afdhal N. On-treatment HCV RNA in patients with varying degrees of fibrosis and cirrhosis in the SOLAR-1 trial. Antivir Ther. 2016;21(6):541-546. doi: 10.3851/IMP3037. Epub 2016 Feb 18.

    PubMed 26891418

  • Charlton M, Everson GT, Flamm SL, Kumar P, Landis C, Brown RS Jr, Fried MW, Terrault NA, O'Leary JG, Vargas HE, Kuo A, Schiff E, Sulkowski MS, Gilroy R, Watt KD, Brown K, Kwo P, Pungpapong S, Korenblat KM, Muir AJ, Teperman L, Fontana RJ, Denning J, Arterburn S, Dvory-Sobol H, Brandt-Sarif T, Pang PS, McHutchison JG, Reddy KR, Afdhal N; SOLAR-1 Investigators. Ledipasvir and Sofosbuvir Plus Ribavirin for Treatment of HCV Infection in Patients With Advanced Liver Disease. Gastroenterology. 2015 Sep;149(3):649-59. doi: 10.1053/j.gastro.2015.05.010. Epub 2015 May 15.

    PubMed 25985734

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LDV/SOF and RBV in people with Chronic HCV Infection, run by Gilead Sciences at 30 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 6 inclusion and 13 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 30 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 15 Apr 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 NCT01938430, 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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