Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SOF · 2 trials · 1 indication
SVR12 is defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 12 weeks after discontinuation of therapy
Collecting all adverse events during the whole study
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment
| Arm | Type | Description |
|---|---|---|
| SOF 400 mg+DAG181 100 mg | EXPERIMENTAL | Patients with genotype 1 HCV infection without cirrhosis will receive SOF 400 mg+DAG181 100 mg for 12 weeks. |
| SOF+DAG181 100 mg | EXPERIMENTAL | Patients with genotype 1 HCV infection without cirrhosis will receive SOF+DAG181 100 mg for 12 weeks. |
| SOF+DAG181 200 mg | EXPERIMENTAL | Patients with genotype 1 HCV infection without cirrhosis will receive SOF+DAG181 200 mg for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| SOF | DRUG | 400 mg tablet administered orally once daily |
| DAG181 | DRUG | 100 mg capsule administered orally once daily |
Inclusion Criteria: 1. Willing and able to provide written informed consent; 2. Male or female, age≥18 years; 3. A female subject is eligible to enter the study if it is confirmed that she is: 1. Of non-childbearing potential (i.e., women who have had a hysterectomy, have both ovaries removed o...
SOF is an investigational small molecule being developed for the treatment of chronic HCV infection, a viral infection of the liver. It is currently in clinical development and has not been approved by regulatory authorities.
SOF is being developed by Sunshine Biopharma Inc., a biopharmaceutical company listed on the stock exchange under the ticker symbol SBFM.
SOF is in Phase 3 clinical development for chronic HCV infection. It has completed a Phase 2 study and a Phase 3 study, both of which are finished, and it remains an investigational drug.
SOF has been studied in two completed clinical trials: NCT03458481, a Phase 2 study of Yimitasvir Phosphate Capsules with 129 participants, and NCT03487107, a Phase 3 study with 362 participants. Both trials enrolled adults with chronic HCV infection in China.
Yes, SOF is also known as Yimitasvir Phosphate, as indicated by the clinical trial titles for the drug. The trials listed for SOF are studies of Yimitasvir Phosphate Capsules.