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

PHASE2CompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

February 16, 2016

Primary Completion Date

January 31, 2018

Study Completion Date

January 31, 2018

Conditions
Chronic Hepatitis D Infection With Hepatitis B
Interventions
DRUG

Myrcludex B

2 mg, once daily, subcutaneously

DRUG

Myrcludex-B

5 mg, once daily, subcutaneously

DRUG

Myrcludex-B

10 mg, once daily, subcutaneously

DRUG

Tenofovir

tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg

Trial Locations (15)

Unknown

Ifi-Institut für interdisziplinäre Medizin an der Asklepios Klinik St. Georg, Hamburg

Universitätsklinikum Hamburg-Eppendorf Medizinische Klinik Studienambulanz Hepatologie, Hamburg

Klinik für Gastroenterologie, Hepatologie und Endokrinologie, Medizinische Hochschule Hannover, Hanover

UniversitätsKlinikum Heidelberg - Medizinische Klinik, Abteilung Klinische Pharmakologie & Pharmakoepidemiologie, Heidelberg

"State Budgetary educational institution of higher professional education South Ural State Medical University Ministry of healthcare", Chelyabinsk

"State Autonomous Healthcare Institution Republican Clinical Infectious Diseases Hospital named after Prof. A.F. Agafonov (SAHI RCID)", Kazan'

"Federal Budget Institution of Science Central Research Institute of Epidemiology of The Federal Service on Customers' Rights Protection and Human Well-being Surveillance", Moscow

"LLC Clinic of Modern Medicine", Moscow

Moscow Regional Research Clinical Institute n.a. M.F. Vladimirskiy, Moscow

"State Budget Health Institution of Moscow Infectious Clinical Hospital No. 1 of the Moscow Healthcare Department", Moscow

"State Budgetary Healthcare Institution Moscow Clinical Scientific and Practical Center of the Department of Public Health of Moscow", Moscow

"State Budgetary Educational Institution of Higher Professional Education Novosibirsk State Medical University of the Ministry of Health of the Russian Federation", Novosibirsk

"Medical Company Hepatolog", Samara

Stavropol Regional Clinical Hospital, Stavropol

"State Budgetary institution of the Republic of Sakha (Yakutia) Yakutsk Clinical Hospital", Yakutsk

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Data Matrix Solutions

OTHER

lead

Hepatera Ltd.

INDUSTRY

NCT03546621 - 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 | Biotech Hunter | Biotech Hunter