drugset / Trial / NCT03954327
Combination Antiretroviral Therapy (cART) for PBC
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2021-03-01
- Primary completion
- 2022-10-01
- Completion
- 2024-01-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Raltegravir | Other / unclassified | 600 mg | Oral |
| Subject | Tenofovir disoproxil fumarate | Small molecule | 300 mg | Oral |
| Subject | emtricitabine | Other / unclassified | 200 mg | Oral |