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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02683005 | Study of Hepatitis C Treatment During Pregnancy | PHASE1 | COMPLETED | 9 | — | — | Sep 1, 2016 | Feb 3, 2020 | Mar 4, 2020 | 1 | United States |
Systemic exposure both LDV and SOF (SOF and inactive metabolite GS-331007) will be assessed at 3 gestational age time points: 1) Late second trimester between 25 + 0 and 26 + 5 weeks' gestation (after at least 10 days of therapy); 2) Early third trimester between 29 + 0 and 30 + 6 weeks' gestation; 3) Late third trimester between 33 + 0 and 34 + 6 weeks' gestation
| Arm | Type | Description |
|---|---|---|
| Ledipasvir/Sofosbuvir | EXPERIMENTAL | Hepatitis C treatment will be initiated with ledipasvir (400 mg) and sofosbuvir (90mg) fixed dose combination, one pill, once daily for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| ledipasvir/sofosbuvir | DRUG | Hepatitis C treatment with ledipasvir and sofosbuvir will be initiated during pregnancy at approximately 24 weeks of gestation. |
Inclusion Criteria: 1. Age 18 through 39 years (inclusive) at Screening 2. Able and willing to provide written informed consent to be screened for and take part in the study procedures 3. Able and willing to provide adequate locator information 4. Chronic HCV, genotype 1, 4, 5, 6 infection, defined...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Atea Pharmaceuticals, Inc. | AVIR | 2 | PHASE3 | Bemnifosbuvir-Ruzasvir, Sofosbuvir-Velpatasvir |
| Abbott Laboratories | ABT | 2 | — | Undisclosed |
| AbbVie, Inc. | ABBV | 1 | — | Undisclosed |