Functional Cure of Hepatitis B in HIV/HBV Co-infected Pat... | NCT05988879

Studies
Functional Cure of Hepatitis B in HIV/HBV Co-infected Patients

NCT05988879

Sponsor

Guangzhou 8th People's Hospital

Status

Recruiting

Last Update Posted

Aug 14, 2023Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

AIDS
Hepatitis B

Interventions

Peginterferon alfa-2b Injection

Countries

China

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

Aug 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2, 2023Actual

Primary Completion Date

Aug 2, 2026Estimated

Completion Date

Aug 2, 2028Estimated

First Submitted Date

Aug 3, 2023

First Submission Date that Met QC Criteria

Aug 3, 2023

First Posted Date

Aug 14, 2023Actual

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

Aug 10, 2023

Last Update Posted Date

Aug 14, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Evaluate the potential of ART combined with interferon therapy to achieve functional cure of hepatitis B in HIV/HBV co-infected patients

Detailed Description

This is a prospective, non-randomized, clinical observational cohort study. The subjects are the advantageous population for functional cure of hepatitis B in HIV/HBV co-infected patients . Depending on whether interferon therapy is used in the real world , the patients are divided into two groups: the ART combined with interferon group and the ART alone group, with 30 cases in each group. Hepatitis B surface antigen seroclearance rate and seroconversion rate will be observed during the study period.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ART combined with interferon group		The treatment protocol is ART combined with pegylated interferon α-2b injection. The pegylated interferon α-2b injection is administered subcutaneously at a dose of 180ug once a week. Follow-up times are at baseline, and during treatment at weeks 4, 8, 12, 24, 36, 48, 60, and 72.	Drug: Peginterferon alfa-2b Injection
ART group		Continuously using ART treatment, without the use of interferon. Follow-up times are at baseline, and during treatment at weeks 12, 24, 36, 48, 60, and 72.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Peginterferon alfa-2b Injection	Drug	The pegylated interferon α-2b injection is administered subcutaneously at a dose of 180ug once a week.	ART combined with interferon group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hepatitis B surface antigen seroclearance	Hepatitis B surface antigen quantification less than 0.05 IU/mL.	48 weeks

Secondary Outcomes

Measure	Description	Time Frame
Hepatitis B surface antigen seroconversion	Clearance of surface antigen concurrently accompanied by the production of surface antibodies	48 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-65 years old, gender unrestricted.
Meeting the People's Republic of China Health Industry Standard (WS293-2008) - "AIDS and HIV Infection Diagnostic Criteria", confirmed as HIV-1 infected.
HBsAg positive for more than 6 months.
At least 1 year of ART treatment prior to screening, and currently undergoing ART treatment with HBsAg <1000IU/mL, HBeAg negative, HBV DNA <100IU/ml, CD4+T lymphocyte count >200 cells/μL and HIV-RNA<20 copies/ml.

Exclusion Criteria:

Pregnant, nursing, planning pregnancy, or with severe mental disorders or uncontrolled epilepsy.
Co-infected with Hepatitis A, C, D, or E viruses.
With other chronic liver diseases like autoimmune hepatitis, drug-induced hepatitis, alcoholic hepatitis, genetic metabolic liver diseases, or moderate to severe fatty liver.
With autoimmune diseases like rheumatoid arthritis, psoriasis, or lupus.
Post organ transplant, planning organ transplant, diagnosed or suspected of liver cancer or other malignant tumors, or undergoing immunosuppressive treatment.
With severe diseases of heart, lungs, kidneys, brain, retinal disorders, or uncontrolled hypertension or diabetes.
Excessive alcohol (average daily alcohol intake >40g for men, >20g for women) or drug users.
Participated in other interventional trials within the last three months, or other situations deemed inappropriate for inclusion by researchers.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

All study participants come from the HIV/HBV co-infection cohort at the Guangzhou Eighth People's Hospital.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Linghua Li, PhD	Contact	+862083710825		llheliza@126.com
Yaozu He, Master	Contact	+862083710825		hyzdyl99@163.com

Overall Officials

Name	Affiliation	Role
Linghua Li, PhD	Guangzhou Eighth People's Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Guangzhou Eighth People's Hospital, Guangzhou Medical University	Recruiting	Guangzhou	Guangdong	510060	China

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

ID	Term
D000163	Acquired Immunodeficiency Syndrome
D006509	Hepatitis B

ID	Term
D015658	HIV Infections
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections