Proof-of-concept Study Evaluating the Safety and Efficacy of EBP921 in Delta Hepatitis (HDV)

NCT01316185 | Terminated Phase 1

• 1 other identifier: EBP-HDV 01-921-01
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to assess the optimal dose of EBP921 by comparing the efficacy and safety of 2 dose regimens in patients with chronic HDV.

Conditions

Hepatitis D

Keywords

Hepatitis D; HDV; Hepatitis

Outcome Measures

Primary Outcomes (1)

• Change in HDV-RNA

  The primary efficacy endpoint will be the median change in HDV-RNA from baseline to HDV RNA nadir as measured by quantitative PCR during the 28-day dosing period.

  28 days

Secondary Outcomes (1)

• Change in HDV RNA from baseline to Day 7, 14, 28 and post therapy weeks 1,2,4,8

  8 Weeks

Study Arms (2)

Group 1

EXPERIMENTAL

Low Dose for 28 days: n=4

Drug: EBP921

Group 2

EXPERIMENTAL

High Dose for 28 days; n=4

Drug: EBP921

Interventions

EBP921 DRUG

Patients randomized to receive low or high dose. All dosing of EBP921 should be taken with food.

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women age 18 or older with the capacity to give written informed consent
• Patients with compensated chronic HDV infection as indicated by presence of anti-HDV in serum.
• Liver biopsy should be performed within one-year of study screening and graded using the Knodell scoring system.
• Presence of HDV antigen in liver tissue or HDV-RNA in serum.
• Active HBV replication will not exclude patients.
• Previous therapy with standard alpha-interferon or peginterferon will not exclude patients.
• Patients who are HBV therapy-naïve or who previously received HBV antiviral therapy will be eligible. Patients currently taking HBV antiviral therapy will e considered on a case basis.
• Female subjects of reproductive potential and female partners of male subjects should be on two reliable forms of contraception from the start of the study until 60 days from the end of EBP921 dosing.

You may not qualify if:

• Severe neuropsychiatric disorders
• History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic heart disease, significant or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic disorders including severe retinopathy, or immune-mediated disease
• Pregnant or breast-feeding patients or the inability to practice adequate contraception during the conduct of the study
• Underlying autoimmune/immune-deficiency disease (e.g., lupus, sarcoidosis, celiac disease, HIV antibody positive, AIDS)
• Chronic (\> 4 weeks duration) diarrhea
• Body weight \> 128 kg and \< 40 kg
• Uncompensated cirrhosis
• Absolute neutrophil count less than 1500 per cubic millimeter
• Platelet count less than 90,000 per cubic millimeter
• Evidence of concurrent HCV infection with positive serum HCVRNA
• Evidence of hepatocellular carcinoma
• Active substance abuse (alcohol, inhaled or injected drugs) within the past 12 months
• Diagnosis of malignancy in the previous five years excluding superficial dermatologic malignancies
• Any experimental therapy in the previous 6 months prior to enrollment.
• \. Patients with a history of multiple drug resistant HBV 17. Patients receiving interferon therapy for any reason.

Sponsors & Collaborators

• Eiger BioPharmaceuticals: lead

Study Sites (2)

Unknown Facility

San Francisco, California, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Hepatitis D; Hepatitis

Condition Hierarchy (Ancestors)

Hepatitis, Viral, Human; Virus Diseases; Infections; RNA Virus Infections; Liver Diseases; Digestive System Diseases

Study Officials

• Brian Murphy, MD, MPH

  Eiger BioPharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2011
• First Posted: March 16, 2011
• Study Start: January 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: August 8, 2016

Record last verified: 2016-08

Locations

US (2)