Hepatitis D, ChronicPhase 2NCT03105310
Pegylated Interferon Alone or in Combination With Ezetimibe for Patients With Chronic Hepatitis D
A Phase 2 study testing Pegylated interferon alfa and Ezetimibe in people with Hepatitis D, Chronic, run by Aga Khan University.
Trial summary
Ezetimibe possesses pharmacophore features to inhibit NTCP, the receptor required for HBV and HDV hepatocyte entry, that include two hydrophobes and one hydrogen bond acceptor. The aim of the study io evaluate the utility of Ezetimibe in combination with pegylated interferon in patients with chronic HDV infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis D, Chronic
- What is being tested?
- Pegylated interferon alfa and Ezetimibe
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jun 2017
- Phase
- Phase 2
- 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
- Presence of anti-HDV in serum
- Presence of quantifiable HDV RNA in serum
- Elevated ALT > ULN
Who cannot join
- Decompensated liver disease
- Patients with ALT levels greater than 10 times ULN (400 U/L)
- Pregnancy or inability to practice adequate contraception.
- Significant systemic or major illnesses other than liver disease, including, but not limited to, congestive heart failure, renal failure (eGFR <50 ml/min), organ transplantation, serious psychiatric disease or depression and active coronary artery disease.
- Systemic immunosuppressive therapy
- Evidence of another form of liver disease in addition to viral hepatitis
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- Active substance abuse, such as alcohol or injection drugs
- Hepatocellular carcinoma
- Concurrent hepatitis C infection or HIV coinfection
- Diagnosis of malignancy in the five years
- Concurrent usage of statins
- Concurrent use of any other drug known to inhibit NTCP
- Inability to understand or sign informed consent
About this study
Ezetimibe possesses pharmacophore features to inhibit NTCP, the receptor required for HBV and HDV hepatocyte entry, that include two hydrophobes and one hydrogen bond acceptor.
The aim of the study io evaluate the utility of Ezetimibe in combination with pegylated interferon in patients with chronic HDV infection.
- Conditions
- Hepatitis D, Chronic
- Being tested
- Pegylated interferon alfa, Ezetimibe
- Keywords
- Hepatitis D, Ezetimibe, Pegylated interferon
- Medical subject headings
- Hepatitis D, Chronic, Hepatitis D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated interferon alfaDrug
Pegylated interferon alfa
EzetimibeDrug
Ezetimibe
| Study group | Role | What they receive |
|---|---|---|
| Pegylated interferon | Active comparator | Pegylated interferon alfa alone 180 microgram subcutaneous weekly for 24 weeks Receives: Drug: Pegylated interferon alfa |
| Pegylated interferon with ezetimibe | Experimental | Pegylated interferon alfa 180 micro-gram subcutaneous weekly for 24 weeks and Ezetimibe 10 mg orally for 24 weeks Receives: Drug: Pegylated interferon alfa; Drug: Ezetimibe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HDV RNA quantitative measurements of >2 logs from baseline
Measured: 24 weeks of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study startJan 2016
- Primary completionDec 2016
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis D, ChronicStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zaigham Abbas, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105310
- Sponsor's protocol ID
- 3636-Med-ERC
- Status last verified
- Mar 2017
- First submitted
- 26 Mar 2017
- Last updated
- 7 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pegylated Interferon Alone or in Combination With Ezetimibe for Patients With Chronic Hepatitis D
- ClinicalTrials.gov ID
- NCT03105310
- Acronym / sponsor ID
- 3636-Med-ERC
- Conditions
- Hepatitis D, Chronic
- Keywords
- Hepatitis D, Ezetimibe, Pegylated interferon
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jun 2017 (estimated)
- First posted
- 7 Apr 2017 (actual)
- 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.
Ezetimibe possesses pharmacophore features to inhibit NTCP, the receptor required for HBV and HDV hepatocyte entry, that include two hydrophobes and one hydrogen bond acceptor.
The aim of the study io evaluate the utility of Ezetimibe in combination with pegylated interferon in patients with chronic HDV infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pegylated interferon | Active comparator | Drug: Pegylated interferon alfaPegylated interferon alfa alone 180 microgram subcutaneous weekly for 24 weeks |
| Pegylated interferon with ezetimibe | Experimental | Drug: Pegylated interferon alfa, Drug: EzetimibePegylated interferon alfa 180 micro-gram subcutaneous weekly for 24 weeks and Ezetimibe 10 mg orally for 24 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Presence of anti-HDV in serum
- Presence of quantifiable HDV RNA in serum
- Elevated ALT > ULN
Key exclusion criteria (13 listed)
- Decompensated liver disease
- Patients with ALT levels greater than 10 times ULN (400 U/L)
- Pregnancy or inability to practice adequate contraception.
- Significant systemic or major illnesses other than liver disease, including, but not limited to, congestive heart failure, renal failure (eGFR <50 ml/min), organ transplantation, serious psychiatric disease or depression and active coronary artery disease.
- Systemic immunosuppressive therapy
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 |
|---|---|---|
| Pegylated interferon alfaPegylated interferon alfa | Drug | Pegylated interferon, Pegylated interferon with ezetimibe |
| EzetimibeEzetimibe | Drug | Pegylated interferon with ezetimibe |
Primary outcome
Change in HDV RNA quantitative measurements of >2 logs from baseline
Time frame: 24 weeks of therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pegylated interferon alfa and Ezetimibe in people with Hepatitis D, Chronic, run by Aga Khan University.
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 3 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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 quantitative measurements of >2 logs from baseline (time frame: 24 weeks of therapy). 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 7 Apr 2017.