Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03954327 | Combination Antiretroviral Therapy (cART) for PBC | PHASE2 | COMPLETED | 37 | — | — | Mar 1, 2021 | Jan 1, 2024 | Feb 16, 2024 | 6 | Canada |
Mean changes in alkaline phosphatase levels after 12 months treatment with combination antiretroviral therapy or placebo.
| Arm | Type | Description |
|---|---|---|
| Emtricitabine (FTC)/Tenofovir Disoproxil (TDF) & Raltegravir | EXPERIMENTAL | one Emtricitabine 200mg and Tenofovir Disoproxil 300mg tablet two Raltegravir 600mg tablets |
| Placebo | PLACEBO_COMPARATOR | Identical tablets resembling one Emtricitabine 200mg and Tenofovir Disoproxil 300mg tablet two Raltegravir 600mg tablets |
| Name | Type | Description |
|---|---|---|
| Emtricitabine (FTC)/Tenofovir Disoproxil (TDF) | DRUG | Emtricitabine (FTC) 200 mg/Tenofovir Disoproxil (TDF) 300 mg by mouth once per day |
| Raltegravir | DRUG | Raltegravir (RTF) 600 mg two tablets by mouth once per day |
| Placebo Oral Capsule [CEBOCAP] | DRUG | Two capsules identical to Raltegravir and one capsule identical to Truvada with no active ingredients by mouth once per day |
Inclusion Criteria: * over 18 years old of either sex, * Anti-mitochondrial antibody +ve or liver histology compatible with PBC, * stable UDCA dose of 13-15 mg/kg for \> 12 months or intolerant to UDCA, * ALP at least 1.67 x ULN or abnormal bilirubin less than 2x ULN * able to read and sign informe...