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

NCT02301936 | Completed Phase 2 Results FDA Drug

• 1 other identifier: GS-US-337-1405
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Hepatitis C Virus Infection

Keywords

Sickle Cell Disease; Gilead; Hepatitis C

Outcome Measures

Primary Outcomes (2)

• 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

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

  Up to 24 weeks

Secondary Outcomes (7)

• Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)

  Posttreatment Week 4

• Percentage of Participants With HCV RNA < LLOQ on Treatment

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

• HCV RNA Change From Baseline

  Up to 24 weeks

• Percentage of Participants With Virologic Failure

  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

  Weeks 4,12, 24, Posttreatment Weeks 4 and 12

Study Arms (2)

LDV/SOF 12 weeks

EXPERIMENTAL

Treatment-naive or treatment-experienced participants without cirrhosis will receive LDV/SOF for 12 weeks.

Drug: LDV/SOF

LDV/SOF 24 weeks

EXPERIMENTAL

Treatment-experienced participants with cirrhosis will receive LDV/SOF for 24 weeks.

Drug: LDV/SOF

Interventions

LDV/SOF DRUG

90/400 mg fixed dose combination (FDC) tablet administered orally once daily

Also known as: Harvoni®, GS-5885/GS-7977

LDV/SOF 12 weeks; LDV/SOF 24 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (1)

Unknown Facility

Lutherville, Maryland, United States

Location

MeSH Terms

Conditions

Hepatitis C; Anemia, Sickle Cell

Interventions

ledipasvir, sofosbuvir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Clinical Trial Disclosures
• Organization: Gilead Sciences

ClinicalTrialDisclosures@gilead.com

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: November 26, 2014
• Study Start: March 2, 2015
• Primary Completion: April 18, 2016
• Study Completion: April 18, 2016
• Last Updated: November 19, 2018
• Results First Posted: May 25, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 18 months after study completion
• Access Criteria: A secured external environment with username, password, and RSA code.

Locations

US (1)