Chronic Hepatitis DPhase 2NCT03099278
Ezetimibe for Patients With Chronic Hepatitis D
A Phase 2 study testing Ezetimibe in people with Chronic Hepatitis D, run by Ziauddin Hospital at 1 site in Pakistan.
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. Therapy with Ezetimibe may lead to decline in hepatitis D virus levels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis D
- What is being tested?
- Ezetimibe
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- Jan 2017to Oct 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
- Treatment experienced patients; non-responders of relapsers of pegylated interferon therapy
- Age 18 years or above
- 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
Show all 14Show fewer
- 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
- Any other condition, which in the opinion of the investigators would impede the patient's participation or compliance in the study
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Ziauddin University Hospital
Karachi, Sindh, 75600
Zaigham Abbas
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. Therapy with Ezetimibe may lead to decline in hepatitis D virus levels. The aim of the study is to evaluate the utility of Ezetimibe in patients with chronic HDV infection
- Conditions
- Chronic Hepatitis D
- Being tested
- Ezetimibe
- Keywords
- hepatitis D, Ezetimibe, HDV RNA
- 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.
EzetimibeDrug
Ezetimibe 20 mg oral daily
| Study group | Role | What they receive |
|---|---|---|
| Ezetimibe | Experimental | Not described Receives: Drug: Ezetimibe |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Decline of HDV RNA quantitative measurements of >1 logs from baseline
Measured: 12 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 posted4 Apr 2017
- Study startJan 2017
- Primary completionJun 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziauddin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zaigham Abbas, Ziauddin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03099278
- Sponsor's protocol ID
- 00281116ZAGE
- Status last verified
- Mar 2017
- First submitted
- 28 Mar 2017
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- 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 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ezetimibe for Patients With Chronic Hepatitis D
- ClinicalTrials.gov ID
- NCT03099278
- Acronym / sponsor ID
- 00281116ZAGE
- Conditions
- Chronic Hepatitis D
- Keywords
- hepatitis D, Ezetimibe, HDV RNA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ziauddin HospitalUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 4 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. Therapy with Ezetimibe may lead to decline in hepatitis D virus levels. The aim of the study is to evaluate the utility of Ezetimibe in patients with chronic HDV infection
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ezetimibe | Experimental | Drug: Ezetimibe |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Treatment experienced patients; non-responders of relapsers of pegylated interferon therapy
- Age 18 years or above
- Presence of anti-HDV in serum
- Presence of quantifiable HDV RNA in serum
- Elevated ALT > ULN
Key exclusion criteria (14 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 |
|---|---|---|
| EzetimibeEzetimibe 20 mg oral daily | Drug | Ezetimibe |
Primary outcome
• Decline of HDV RNA quantitative measurements of >1 logs from baseline
Time frame: 12 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 4 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ezetimibe in people with Chronic Hepatitis D, run by Ziauddin Hospital at 1 site in Pakistan.
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 5 inclusion and 14 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 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. 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 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?
Contact Zaigham Abbas (922135862937, drzabbas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Decline of HDV RNA quantitative measurements of >1 logs from baseline (time frame: 12 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 4 Apr 2017.