- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02301936
Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 or 24 Weeks in Genotype 1 or 4 HCV Infected Adults With Sickle Cell Disease
October 19, 2018 updated by: Gilead Sciences
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).
Study Overview
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Maryland
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Lutherville, Maryland, United States
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Key Inclusion Criteria:
- 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:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LDV/SOF 12 weeks
Treatment-naive or treatment-experienced participants without cirrhosis will receive LDV/SOF for 12 weeks.
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90/400 mg fixed dose combination (FDC) tablet administered orally once daily
Other Names:
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Experimental: LDV/SOF 24 weeks
Treatment-experienced participants with cirrhosis will receive LDV/SOF for 24 weeks.
|
90/400 mg fixed dose combination (FDC) tablet administered orally once daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Time Frame: Up to 24 weeks
|
Up to 24 weeks
|
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Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
Time Frame: Posttreatment Week 12
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SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
|
Posttreatment Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)
Time Frame: Posttreatment Week 4
|
SVR4 was defined as HCV RNA < the LLOQ 4 weeks following the last dose of study drug.
|
Posttreatment Week 4
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Time Frame: Weeks 1, 2, 4, 8,12, 16, 20, and 24
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Weeks 1, 2, 4, 8,12, 16, 20, and 24
|
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HCV RNA Change From Baseline
Time Frame: Up to 24 weeks
|
Up to 24 weeks
|
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Percentage of Participants With Virologic Failure
Time Frame: Up to Posttreatment Week 12
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Virologic failure was defined as
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Up to Posttreatment Week 12
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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
|
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.
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Weeks 4,12, 24, Posttreatment Weeks 4 and 12
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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
|
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.
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Weeks 4,12, 24, Posttreatment Weeks 4 and 12
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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
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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.
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Weeks 4,12, 24, Posttreatment Weeks 4 and 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 2, 2015
Primary Completion (Actual)
April 18, 2016
Study Completion (Actual)
April 18, 2016
Study Registration Dates
First Submitted
November 24, 2014
First Submitted That Met QC Criteria
November 24, 2014
First Posted (Estimate)
November 26, 2014
Study Record Updates
Last Update Posted (Actual)
November 19, 2018
Last Update Submitted That Met QC Criteria
October 19, 2018
Last Verified
April 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Hematologic Diseases
- Liver Diseases
- Genetic Diseases, Inborn
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Anemia
- Anemia, Hemolytic, Congenital
- Anemia, Hemolytic
- Hemoglobinopathies
- Hepatitis
- Hepatitis C
- Anemia, Sickle Cell
- Anti-Infective Agents
- Antiviral Agents
- Sofosbuvir
- Ledipasvir, sofosbuvir drug combination
- Ledipasvir
Other Study ID Numbers
- GS-US-337-1405
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
IPD Sharing Time Frame
18 months after study completion
IPD Sharing Access Criteria
A secured external environment with username, password, and RSA code.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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