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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

NCT03546621 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-05-10

Study results available
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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

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

Sponsors & Collaborators

  • Data Matrix Solutions

    collaborator OTHER

  • Hepatera Ltd.

    lead INDUSTRY

Principal Investigators

  • Heiner Wedemeyer, MD,PhD · Dept. of Gastroenterology, Hepatology and Endocrinology Medizinische Hochschule Hannover

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-16
Primary Completion
2018-01-31
Completion
2018-01-31

Countries

  • Germany
  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03546621 on ClinicalTrials.gov