At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 120 enrolled
Drug / intervention
Myrcludex B +3 moredrug
Likely dose
Myrcludex B 2 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Open-label, Randomized Clinical Study to Assess Efficacy and Safety of 3 Doses of Myrcludex B for 24 Weeks in Combination With Tenofovir Compared to Tenofovir Alone to Suppress HBV Replication in Patients With Chronic Hepatitis D
In Brief
A Phase 2 clinical trial evaluating Myrcludex B, Myrcludex-B, and 1 other intervention for Chronic Hepatitis D Infection With Hepatitis B. Completed, enrolled 120 participants across 15 sites in 2 countries.
Detailed Summary
This is a multicenter, open-label, randomized clinical trial to Assess Efficacy and Safety of 3 Doses of Myrcludex B for 24 Weeks in Combination with Tenofovir Compared to Tenofovir Alone to Suppress HBV Replication in Patients with Chronic Hepatitis D
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany, Russia
CollaboratorsData Matrix Solutions
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartFeb 2016
Primary CompletionJan 2018
First PostedJun 2018
TodayJul 2026
First PostedJun 6, 2018
Enrollment StartFeb 16, 2016
Primary CompletionJan 31, 2018
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 8.1 years ago
Interventions
Myrcludex Bdrug
2 mg, once daily, subcutaneously
Myrcludex-Bdrug
5 mg, once daily, subcutaneously
Myrcludex-Bdrug
10 mg, once daily, subcutaneously
Tenofovirdrug
tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg