Hepatitis DPhase 1NCT01316185
Proof-of-concept Study Evaluating the Safety and Efficacy of EBP921 in Delta Hepatitis (HDV)
A Phase 1 study testing EBP921 in people with Hepatitis D, run by Eiger BioPharmaceuticals at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis D
- What is being tested?
- EBP921
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2011to Apr 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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.
- 16. Patients with a history of multiple drug resistant HBV 17. Patients receiving interferon therapy for any reason.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Henry Ford Hospital
Detroit, Michigan, 48202
Study site
San Francisco, California
About this study
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)
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.
Read the 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.
- Conditions
- Hepatitis D
- Being tested
- EBP921
- Keywords
- Hepatitis D, HDV, Hepatitis
- Medical subject headings
- Hepatitis D, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBP921Drug
Patients randomized to receive low or high dose. All dosing of EBP921 should be taken with food.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Low Dose for 28 days: n=4 Receives: Drug: EBP921 |
| Group 2 | Experimental | High Dose for 28 days; n=4 Receives: Drug: EBP921 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (1)
Change in HDV RNA from baseline to Day 7, 14, 28 and post therapy weeks 1,2,4,8
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.
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2011 (estimated)
- Study startJan 2011
- Primary completionApr 2013
- Study completionApr 2013
Why it stopped: the enrollment was slow and never completed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis DStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eiger BioPharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Murphy, MD, MPH, Study director, Eiger BioPharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01316185
- Sponsor's protocol ID
- EBP-HDV 01-921-01
- Status last verified
- Aug 2016
- First submitted
- 14 Mar 2011
- Last updated
- 8 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01316185
- Acronym / sponsor ID
- EBP-HDV 01-921-01
- Conditions
- Hepatitis D
- Keywords
- Hepatitis D, HDV, Hepatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the enrollment was slow and never completed.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Eiger BioPharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 16 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: EBP921Low Dose for 28 days: n=4 |
| Group 2 | Experimental | Drug: EBP921High Dose for 28 days; n=4 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EBP921Patients randomized to receive low or high dose. All dosing of EBP921 should be taken with food. | Drug | Group 1, Group 2 |
Primary outcome
Change in HDV-RNA
Time frame: 28 days
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.
1 secondary outcome
Change in HDV RNA from baseline to Day 7, 14, 28 and post therapy weeks 1,2,4,8
Time frame: 8 Weeks
Results and safety
The study was stopped early (reason given: the enrollment was slow and never completed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2016.
Related trials for Hepatitis D
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
RecruitingObservational study
Effectiveness and Safety of Bulevirtide (BLV) Therapy in Patients With Chronic Hepatitis Delta (CHD) in Italy (D-SHIELD)
Hepatitis D
Active, not recruitingPhase 3
A Study to Evaluate Tobevibart + Elebsiran in Chronic HDV Infection
Viral Hepatitis
Not yet recruitingPhase 3
Phase III Clinical Trial of Hepalatide in Patients With Chronic Hepatitis D
Hepatitis D, Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Murphy, MD, MPH study director
Eiger BioPharmaceuticals, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EBP921 in people with Hepatitis D, run by Eiger BioPharmaceuticals at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: the enrollment was slow and never completed.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HDV-RNA (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2016.