Pegylated Interferon Alone or in Combination With Ezetimi... | NCT03105310

Studies
Pegylated Interferon Alone or in Combination With Ezetimibe for Patients With Chronic Hepatitis D

NCT03105310

Sponsor

Aga Khan University

Status

Unknown status

Last Update Posted

Apr 7, 2017Actual

Enrollment

20Estimated

Phase

Phase 2

Conditions

Hepatitis D, Chronic

Interventions

Pegylated interferon alfa
Ezetimibe

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016Actual

Primary Completion Date

Dec 2016Actual

Completion Date

Jun 2017Estimated

First Submitted Date

Mar 26, 2017

First Submission Date that Met QC Criteria

Apr 3, 2017

First Posted Date

Apr 7, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 3, 2017

Last Update Posted Date

Apr 7, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pegylated interferon	Active Comparator	Pegylated interferon alfa alone 180 microgram subcutaneous weekly for 24 weeks	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	Drug: Pegylated interferon alfa Drug: Ezetimibe

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pegylated interferon alfa	Drug	Pegylated interferon alfa	Pegylated interferon Pegylated interferon with ezetimibe

Measure	Description	Time Frame
Change in HDV RNA quantitative measurements of >2 logs from baseline		24 weeks of therapy

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Presence of anti-HDV in serum
Presence of quantifiable HDV RNA in serum
Elevated ALT > ULN

Exclusion Criteria:

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
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D019701	Hepatitis D, Chronic
D003699	Hepatitis D

Ancestor Terms

ID	Term
D006525	Hepatitis, Viral, Human
D014777	Virus Diseases
D007239	Infections
D012327	RNA Virus Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069438	Ezetimibe

Ancestor Terms

ID	Term
D001384	Azetidines
D001385	Azetines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided