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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Eiger BioPharmaceuticals.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Eiger BioPharmaceuticals
ClinicalTrials.gov Identifier:
NCT01316185
First received: March 14, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Hepatitis D
 Drug: EBP921
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Dose-ranging Proof-of-concept Study Assessing the Safety and Efficacy of EBP921 in Therapy-naive Patients Chronically Infected With Delta Hepatitis (HDV)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eiger BioPharmaceuticals:

Primary Outcome Measures:
  • Change in HDV-RNA [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change in HDV RNA from baseline to Day 7, 14, 28 and post therapy weeks 1,2,4,8 [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
    The median change in HDV RNA from baseline to Days 7, 14, 28, and post-therapy Weeks 1, 2, 4, and 8 of the study; the proportion of patients with alanine aminotransferase (ALT) normalization defined as ALT ≤ upper limit of normal for patients with ALT > ULN at baseline; assessment of peripheral blood mononuclear cell (PBMC) proliferation after 14 and 28 days exposure to EBP921; the percentage of patients with undetectable HDV RNA at Days 7, 14, 28, post-therapy Weeks 1, 2, 4, and 8; the median change in HBV DNA at Days 7, 14, 21, 28, 35, and 42, and HBsAg at Days 14, 28, and 42.


Estimated Enrollment: 8
Study Start Date: January 2011
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Low Dose for 28 days: n=4
 Drug: EBP921
Patients randomized to receive low or high dose. All dosing of EBP921 should be taken with food.
Experimental: Group 2
High Dose for 28 days; n=4
 Drug: EBP921
Patients randomized to receive low or high dose. All dosing of EBP921 should be taken with food.

Detailed Description:

This is an open-label, phase 1b, proof-of-concept study to assess the safety and efficacy of EBP921, a prenylation inhibitor, in subjects chronically infected with delta hepatitis. Subjects will be randomized to receive one of two different doses of EBP921. Dosing will occur over 28-days and during that time, evidence of antiviral response will be assessed by frequent measurements of HDV-RNA via PCR assay. In addition, safety lab data will also be collected along with surveillance monitoring of HBV activity.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women age 18 or older with the capacity to give written informed consent
  2. Patients with compensated chronic HDV infection as indicated by presence of anti-HDV in serum.
  3. Liver biopsy should be performed within one-year of study screening and graded using the Knodell scoring system.
  4. Presence of HDV antigen in liver tissue or HDV-RNA in serum.
  5. Active HBV replication will not exclude patients.
  6. Previous therapy with standard alpha-interferon or peginterferon will not exclude patients.
  7. 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.
  8. 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.

Exclusion Criteria:

  1. Severe neuropsychiatric disorders
  2. 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
  3. Pregnant or breast-feeding patients or the inability to practice adequate contraception during the conduct of the study
  4. Underlying autoimmune/immune-deficiency disease (e.g., lupus, sarcoidosis, celiac disease, HIV antibody positive, AIDS)
  5. Chronic (> 4 weeks duration) diarrhea
  6. Body weight > 128 kg and < 40 kg
  7. Uncompensated cirrhosis
  8. Absolute neutrophil count less than 1500 per cubic millimeter
  9. Platelet count less than 90,000 per cubic millimeter
  10. Evidence of concurrent HCV infection with positive serum HCVRNA
  11. Evidence of hepatocellular carcinoma
  12. Active substance abuse (alcohol, inhaled or injected drugs) within the past 12 months
  13. Diagnosis of malignancy in the previous five years excluding superficial dermatologic malignancies
  14. Any experimental therapy in the previous 6 months prior to enrollment.

16. Patients with a history of multiple drug resistant HBV 17. Patients receiving interferon therapy for any reason.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01316185

Contacts
Contact: Brian Murphy, MD, MPH 6508048533 bmurphy@eigerbio.com

Locations
United States, California
Recruiting
San Francisco, California, United States
United States, Michigan
Recruiting
Detroit, Michigan, United States
Sponsors and Collaborators
Eiger BioPharmaceuticals
Investigators
Study Director: Brian Murphy, MD, MPH Eiger BioPharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Brian Murphy, MD, MPH, Chief Medical Officer, Eiger BioPharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01316185     History of Changes
Other Study ID Numbers: EBP-HDV 01-921-01
Study First Received: March 14, 2011
Last Updated: March 14, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Eiger BioPharmaceuticals:
Hepatitis D
HDV
Hepatitis

Additional relevant MeSH terms:
Hepatitis D
Hepatitis
Hepatitis A
Hepatitis, Viral, Human
Virus Diseases
 RNA Virus Infections
Liver Diseases
Digestive System Diseases
Enterovirus Infections
Picornaviridae Infections

ClinicalTrials.gov processed this record on May 16, 2013