Ledipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Nosocomial Genotype 1 HCV Infection

NCT01924949 | Completed Phase 2 Results

• 1 other identifier: GS-US-337-0125
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with nosocomial genotype 1 hepatitis C virus (HCV) infection.

Conditions

Hepatitis C

Keywords

7977; 5885; GS-7977; GS-5885; SOF; LDV; Sofosbuvir; Ledipasvir; FDC

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)

  SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.

  Posttreatment Week 12

• Percentage of Participants Permanently Discontinuing Study Drug Due to an Adverse Event

  Up to 12 weeks

Secondary Outcomes (4)

• Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

  Posttreatment Weeks 4 and 24

• Percentage of Participants With HCV RNA < LLOQ on Treatment

  Up to 12 weeks

• HCV RNA Change From Baseline

  Baseline; Weeks 1, 4, and 8

• Percentage of Participants Experiencing Virologic Failure

  Baseline to posttreatment Week 24

Study Arms (1)

LDV/SOF

EXPERIMENTAL

Participants will receive LDV/SOF FDC for 12 weeks.

Drug: LDV/SOF

Interventions

LDV/SOF DRUG

Ledipasvir (LDV)/sofosbuvir (SOF) 90/400 mg FDC tablet administered orally once daily

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

LDV/SOF

Eligibility Criteria

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

You may qualify if:

• Body mass index (BMI) greater than or equal to 18 kg/m\^2.
• HCV RNA greater than or equal to 1000 IU/mL at screening.
• Documented acquisition of nosocomial genotype 1 HCV infection within 36 months from the screening visit.
• Screening laboratory values within predefined thresholds.
• Use of two effective contraception methods if female of childbearing potential or sexually active male.
• Healthy according to medical history and physical examination with the exception of HCV diagnosis.

You may not qualify if:

• Unstable cardiac disease including subjects with active angina pectoris and/or hospitalization for a cardiac condition within 24 weeks prior to screening.
• Prior exposure to an HCV NS5a inhibitor.
• Pregnant or nursing female.
• Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
• History of solid organ transplantation.
• Current or prior history of clinical hepatic decompensation.
• History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol.
• Known hypersensitivity to LDV, SOF, or formulation excipients.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (1)

Unknown Facility

Boston, Massachusetts, United States

Location

MeSH Terms

Conditions

Hepatitis C

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

Results Point of Contact

• Title: Clinical Trial Disclosures
• Organization: Gilead Sciences

ClinicalTrialDisclosures@gilead.com

Study Officials

• Luisa Stamm, MD, PhD

  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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2013
• First Posted: August 19, 2013
• Study Start: July 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: August 1, 2014
• Last Updated: November 19, 2018
• Results First Posted: May 29, 2015

Record last verified: 2015-05

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)