Hepatitis C Virus InfectionPhase 2NCT02301936
Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 or 24 Weeks in Genotype 1 or 4 HCV Infected Adults With Sickle Cell Disease
A Phase 2 study testing LDV/SOF in people with Hepatitis C Virus Infection, run by Gilead Sciences at 1 site in United States.
Trial summary
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for 12 or 24 weeks in adults with genotype 1 or 4 hepatitis C virus (HCV) infection with sickle cell disease (SCD). 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2015to 18 Apr 2016
- 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
- Chronic genotype 1 or 4 infected patients with sickle cell disease
- HCV RNA ≥ 1,000 IU/mL at screening
- Cirrhosis determination by transient elastography
- Screening laboratory values within defined thresholds
- Use of two effective contraception methods if female of childbearing potential or sexually active male
Who cannot join
- Pregnant or nursing female
- Co-infection with HIV or hepatitis B virus (HBV)
- Current or prior history of clinical hepatic decompensation
- Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
- History of clinically significant illness or any other medical disorder that may interfere with treatment, assessment or compliance with the protocol
- Note: Other protocol defined inclusion/Exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Study of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 or 24 Weeks in Genotype 1 or 4 HCV Infected Subjects With Sickle Cell Disease
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for 12 or 24 weeks in adults with genotype 1 or 4 hepatitis C virus (HCV) infection with sickle cell disease (SCD).
- Conditions
- Hepatitis C Virus Infection
- Being tested
- LDV/SOF
- Keywords
- Sickle Cell Disease, Gilead, Hepatitis C
- Medical subject headings
- Hepatitis C, Anemia, Sickle Cell
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 fixed dose combination (FDC) tablet administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| LDV/SOF 12 weeks | Experimental | Treatment-naive or treatment-experienced participants without cirrhosis will receive LDV/SOF for 12 weeks. Receives: Drug: LDV/SOF |
| LDV/SOF 24 weeks | Experimental | Treatment-experienced participants with cirrhosis will receive LDV/SOF for 24 weeks. Receives: Drug: LDV/SOF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Measured: Up to 24 weeks
Secondary outcomes (7)
Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA < the LLOQ 4 weeks following the last dose of study drug.
Measured: Posttreatment Week 4
Percentage of Participants With HCV RNA < LLOQ on Treatment
Measured: Weeks 1, 2, 4, 8,12, 16, 20, and 24
HCV RNA Change From Baseline
Measured: Up to 24 weeks
Percentage of Participants With Virologic Failure
Virologic failure was defined as
- On-treatment virologic failure
- HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment,
- > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, 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 12
Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Physical Component Score
The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). The first 6 concepts constitute the physical component summary. The total score is an average of the individual question scores, which are scaled 0-100 with lower scores representing more disability and higher scores representing less disability.
Measured: Weeks 4,12, 24, Posttreatment Weeks 4 and 12
Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Mental Component Score
The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). The last 5 concepts constitute the mental component summary. The total score is an average of the individual question scores, which are scaled 0-100 with lower score representing more disability and higher scores representing less disability.
Measured: Weeks 4,12, 24, Posttreatment Weeks 4 and 12
Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
The FACIT-Fatigue score was measured using a 40-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale from 0 (Not at all) to 4 (Very much). The FACIT-F total score was calculated by taking the sum of all 40 individual scores and ranged from 0-160, with higher scores indicating better quality of life.
Measured: Weeks 4,12, 24, Posttreatment Weeks 4 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2014 (estimated)
- Study start2 Mar 2015
- Primary completion18 Apr 2016
- Study completion18 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatitis C Virus InfectionStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301936
- Sponsor's protocol ID
- GS-US-337-1405
- Status last verified
- Apr 2017
- First submitted
- 24 Nov 2014
- Last updated
- 19 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 or 24 Weeks in Genotype 1 or 4 HCV Infected Subjects With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT02301936
- Acronym / sponsor ID
- GS-US-337-1405
- Conditions
- Hepatitis C Virus Infection
- Keywords
- Sickle Cell Disease, Gilead, Hepatitis C
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2015 (actual)
- Primary completion
- 18 Apr 2016 (actual)
- Study completion
- 18 Apr 2016 (actual)
- First posted
- 26 Nov 2014 (estimated)
- Results
- Posted 25 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for 12 or 24 weeks in adults with genotype 1 or 4 hepatitis C virus (HCV) infection with sickle cell disease (SCD).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LDV/SOF 12 weeks | Experimental | Drug: LDV/SOFTreatment-naive or treatment-experienced participants without cirrhosis will receive LDV/SOF for 12 weeks. |
| LDV/SOF 24 weeks | Experimental | Drug: LDV/SOFTreatment-experienced participants with cirrhosis will receive LDV/SOF for 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chronic genotype 1 or 4 infected patients with sickle cell disease
- HCV RNA ≥ 1,000 IU/mL at screening
- Cirrhosis determination by transient elastography
- Screening laboratory values within defined thresholds
- Use of two effective contraception methods if female of childbearing potential or sexually active male
Key exclusion criteria (6 listed)
- Pregnant or nursing female
- Co-infection with HIV or hepatitis B virus (HBV)
- Current or prior history of clinical hepatic decompensation
- Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
- History of clinically significant illness or any other medical disorder that may interfere with treatment, assessment or compliance with the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LDV/SOFAlso: Harvoni®, GS-5885/GS-797790/400 mg fixed dose combination (FDC) tablet administered orally once daily | Drug | LDV/SOF 12 weeks, LDV/SOF 24 weeks |
Primary outcome
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
Time frame: Posttreatment Week 12
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Time frame: Up to 24 weeks
7 secondary outcomes
Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)
Time frame: Posttreatment Week 4
Percentage of Participants With HCV RNA < LLOQ on Treatment
Time frame: Weeks 1, 2, 4, 8,12, 16, 20, and 24
HCV RNA Change From Baseline
Time frame: Up to 24 weeks
Percentage of Participants With Virologic Failure
Time frame: Up to Posttreatment Week 12
Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Physical Component Score
Time frame: Weeks 4,12, 24, Posttreatment Weeks 4 and 12
Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Mental Component Score
Time frame: Weeks 4,12, 24, Posttreatment Weeks 4 and 12
Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Time frame: Weeks 4,12, 24, Posttreatment Weeks 4 and 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: 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.
Related trials for Hepatitis C Virus Infection
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Not yet recruitingPhase 4
Combating Related Epidemics in HCV
HIV - Human Immunodeficiency Virus, Hepatitis B Virus (HBV)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LDV/SOF in people with Hepatitis C Virus Infection, run by Gilead Sciences at 1 site 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 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 19 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 1 site 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 25 May 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?
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 19 Nov 2018.