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Combination Antiretroviral Therapy (cART) for PBC

NCT03954327 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2024-02-16

No results posted yet for this study

Summary

Placebo Controlled, double-blind randomized controlled trial (RCT) with 12 months Tenofovir Disoproxil and Raltegravir for primary biliary cholangitis (PBC) patients unresponsive to Ursodeoxycholic Acid (UDCA). Placebo patients will be offered 12 months open label therapy at unblinding. All patients will be offered an additional 12 months open label therapy. Observational, open label study will be performed in parallel using Emtricitabine (FTC)/Tenofovir Disoproxil (TDF) \& Raltegravir in liver transplant recipients meeting all entry criteria except for use of immunosuppression.

Conditions

Interventions

DRUG

Emtricitabine (FTC)/Tenofovir Disoproxil (TDF)

Emtricitabine (FTC) 200 mg/Tenofovir Disoproxil (TDF) 300 mg by mouth once per day

DRUG

Raltegravir

Raltegravir (RTF) 600 mg two tablets by mouth once per day

DRUG

Placebo Oral Capsule [CEBOCAP]

Two capsules identical to Raltegravir and one capsule identical to Truvada with no active ingredients by mouth once per day

Sponsors & Collaborators

Principal Investigators

  • Andrew Mason, MD · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2022-10-01
Completion
2024-01-01

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03954327 on ClinicalTrials.gov