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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03118674 | Harvoni Treatment Porphyria Cutanea Tarda | PHASE2 | COMPLETED | 23 | — | — | Sep 6, 2017 | Mar 4, 2022 | Jul 3, 2023 | 3 | United States |
Resolution of active PCT, defined as normalization of plasma porphyrins (less than 0.9 mcg/dL) by 7 months after start of therapy
| Arm | Type | Description |
|---|---|---|
| Harvoni | EXPERIMENTAL | 1 tablet per day, oral, taken with or without food. 8 weeks for patients without cirrhosis, not previously treated with HCV GT1 and HCV rNA \< 6 million IU/mL; 12 weeks for patients without cirrhosis; 24 weeks for patients with compensated cirrhosis |
| Name | Type | Description |
|---|---|---|
| Harvoni | DRUG | One capsule of Harvoni/ ledipasvir, 90 mg + sofosbuvir, 400 mg administered daily for 8, 12, or 24 weeks |
Inclusion Criteria 1. Willing and able to give informed consent 2. ≥18 years of age 3. Symptoms and signs consistent with PCT and well documented biochemical diagnosis (urinary total porphyrin excretion \> 500 mcg/g Creatinine with HPLC pattern typical of PCT-predominance of 8- and 7-carboxyl porph...