Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination (FDC) for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic HCV Infection

NCT02251717 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: GS-US-337-14062014-002121-35
• Study Type: interventional
• Target: 114
• Locations: 4 countries
• Sites: 5

Brief Summary

This study will evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) for 12 or 24 weeks in adults with chronic genotype 1 or genotype 4 hepatitis C virus (HCV) infection who have had a kidney transplant.

Conditions

Hepatitis C Virus Infection

Keywords

renal transplant

Outcome Measures

Primary Outcomes (2)

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

  SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.

  Posttreatment Week 12

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

  Up to 24 weeks

Secondary Outcomes (2)

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

  Posttreatment Weeks 4 and 24

• Percentage of Participants With Virologic Failure

  Up to Posttreatment Week 24

Study Arms (2)

LDV/SOF 12 wk

EXPERIMENTAL

Participants will receive LDV/SOF FDC for 12 weeks.

Drug: LDV/SOF

LDV/SOF 24 wk

EXPERIMENTAL

Participants will receive LDV/SOF FDC for 24 weeks.

Drug: LDV/SOF

Interventions

LDV/SOF DRUG

90/400 mg FDC tablet administered orally once daily

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

LDV/SOF 12 wk; LDV/SOF 24 wk

Eligibility Criteria

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

You may qualify if:

• Genotype 1 or 4 chronic HCV infection
• Have received a kidney transplant more than 6 months before the Baseline visit
• Cirrhosis determination
• Screening laboratory parameters 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 or male with pregnant female partner
• 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 subject treatment, assessment or compliance with the protocol
• Planned or anticipated second kidney transplant

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (5)

Unknown Facility

Vienna, Austria

Location

Unknown Facility

Marseille, France

Location

Unknown Facility

Paris, France

Location

Unknown Facility

Hanover, Germany

Location

Unknown Facility

Milan, Italy

Location

Related Publications (2)

• Colombo M, Aghemo A, Liu H, Dvory-Sobol H, Hyland RH, Yun C, Brainard DM, McHutchison JG, Bourliere M, Peck-Radosavljevic M, Manns M, Pol S. Ledipasvir/Sofosbuvir (LDV/SOF) for 12 or 24 Weeks Is Safe and Effective in Kidney Transplant Recipients With Chronic Genotype 1 or 4 HCV Infection. Journal of Hepatology. 2016;64 pp S183-S212. (GS 13, oral presentation).

  RESULT

• Colombo M, Aghemo A, Liu H, Zhang J, Dvory-Sobol H, Hyland R, Yun C, Massetto B, Brainard DM, McHutchison JG, Bourliere M, Peck-Radosavljevic M, Manns M, Pol S. Treatment With Ledipasvir-Sofosbuvir for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic Hepatitis C Virus Genotype 1 or 4 Infection: A Randomized Trial. Ann Intern Med. 2017 Jan 17;166(2):109-117. doi: 10.7326/M16-1205. Epub 2016 Nov 15.

  PMID: 27842383 RESULT

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

• 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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2014
• First Posted: September 29, 2014
• Study Start: October 14, 2014
• Primary Completion: March 24, 2016
• Study Completion: June 16, 2016
• Last Updated: November 19, 2018
• Results First Posted: November 17, 2017

Record last verified: 2017-11

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

IT (1); FR (2); AU (1); DE (1)