Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 or 24 Weeks in Genotype 1 or 4 HCV Infected Adults With Sickle Cell Disease

Hepatitis C Virus Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02301936
• Other study ID #: GS-US-337-1405
• Status: Completed
• Phase: Phase 2
• Start date: March 2, 2015
• Est. completion date: April 18, 2016

Study information

• Verified date: April 2017
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 18, 2016
• Est. primary completion date: April 18, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Hepatitis
• Hepatitis C
• Hepatitis C Virus Infection
• Virus Diseases

Intervention

Drug:
• LDV/SOF
90/400 mg fixed dose combination (FDC) tablet administered orally once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Posttreatment Week 12
Primary	Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event		Up to 24 weeks
Secondary	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.	Posttreatment Week 4
Secondary	Percentage of Participants With HCV RNA < LLOQ on Treatment		Weeks 1, 2, 4, 8,12, 16, 20, and 24
Secondary	HCV RNA Change From Baseline		Up to 24 weeks
Secondary	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	Up to Posttreatment Week 12
Secondary	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.	Weeks 4,12, 24, Posttreatment Weeks 4 and 12
Secondary	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.	Weeks 4,12, 24, Posttreatment Weeks 4 and 12
Secondary	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.	Weeks 4,12, 24, Posttreatment Weeks 4 and 12