3 result(s) found
The primary objective of the study is to assess the clinical efficacy of repeat subcutaneous (SC) doses of dupilumab, compared with placebo, to relieve symptoms in adult patients with active, moderate to severe eosinophilic esophagitis (EoE).
This is a randomized, double-blind, placebo-controlled, multicenter Phase 2 study to evaluate the safety and efficacy of administering either 1 mg, 2 mg or 4 mg of GS-9620 orally once a week (every 7 days) both in-clinic and at home for 12 doses (Weeks 0-11) in adult CHB subjects who are not currently on treatment for CHB.
Approximately 175 subjects will be randomized in a 1:2:2:2 ratio to one of the four treatment arms (A:B: C: D) for weekly dosing for a total of 12 doses. All subjects will also be treated with Tenofovir
Disoproxil Fumarate (TDF) 300 mg oral daily for 48 weeks. Randomization will be stratified by HBeAg status (positive vs. negative) and ALT (> vs. <19 IU/L for female; > vs. < 30 IU/L for male).
- Treatment Arm A: 25 subjects administered TDF 300 mg oral daily + placebo orally once a week (every 7 days) for 12 doses
- Treatment Arm B: 50 subjects administered TDF 300 mg oral daily + GS-9620 1 mg orally once a week every 7 days) for 12 doses
- Treatment Arm C: 50 subjects administered TDF 300 mg oral daily +GS- 9620 2 mg orally once a week every 7 days) for 12 doses
- Treatment Arm D: 50 subjects administered TDF 300 mg oral daily + GS-9620 4 mg orally once a week (every 7 days) for 12 doses
After Week 11, GS-9620/placebo will be discontinued. All subjects will continue receiving TDF and will be followed for 37 weeks (Week 48).
The main purpose of this research study is to investigate the effectiveness of avatombopag (the study drug under investigation) in increasing the amount of platelets (a type of cell found in the blood) in patients with chronic liver disease who need to have an elective procedure but have thrombocytopenia (low platelet counts) related to chronic liver disease. This study will look if avatrombopag has the ability to increase your platelet count high enough for you to have an elective procedure and lower the need for procedure-related platelet transfusions.