Hepatitis B in Cystic Fibrosis and Latent Tuberculosis Re... | NCT02605538

Studies
Hepatitis B in Cystic Fibrosis and Latent Tuberculosis Respectively

NCT02605538

Sponsor

Karolinska University Hospital

Status

Withdrawn

Last Update Posted

Mar 18, 2024Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Cystic Fibrosis
Hepatitis A
Hepatitis B
Tuberculosis

Interventions

Vaccination with vaccine against hepatitis A and B

Countries

Sweden

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 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Time and resource deficiency at the Stockholm CF Center.

Expanded Access Info

Start Date

Sep 1, 2015Actual

Primary Completion Date

Dec 2023Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

May 4, 2015

First Submission Date that Met QC Criteria

Nov 11, 2015

First Posted Date

Nov 16, 2015Estimated

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

Mar 15, 2024

Last Update Posted Date

Mar 18, 2024Actual

Name	Class
Karolinska Institutet	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

CF patients are at risk for hepatic disease. Vaccination is recommended to all CF patients according to European consensus. The aim of the study is to vaccinate as many patients as possible and to follow up whether immunization has been complete.

Detailed Description

Initially, healthy volunteers will be vaccinated to be compared with patients' antibody response to hepatitis A and B vaccine.

The connected part of this study is to vaccinate children suffering from latent tuberculosis against hepatitis B and to measure whether the immunization is related to specific interferon gamma response against Mycobacterium tuberculosis.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cystic Fibrosis	Active Comparator	Vaccination with Twinrix (TM), 3 doses within 6 months according to the manufacturer's instruction. The response will be studied in a time frame of 6 months.	Biological: Vaccination with vaccine against hepatitis A and B
Healthy volunteers	Active Comparator	Vaccination with Twinrix (TM), 3 doses within 6 months according to the manufacturer's instruction. The response will be studied in a time frame of 6 months.	Biological: Vaccination with vaccine against hepatitis A and B

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vaccination with vaccine against hepatitis A and B	Biological	Vaccination against hepatitis A and B	Cystic Fibrosis Healthy volunteers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Positive antibody response to vaccination with Twinrix(TM) in CF patients compared to healthy volunteers		6 months for vaccination

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

CF patients not previously immunized against hepatitis A or B
Healthy volunteers not previously immunized against hepatitis A or B
Age over 1 year

Exclusion Criteria:

Previously transplanted patients
Previous vaccination with hepatitis vaccine
Known allergy against components in Twinrix (TM)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ferenc Karpati, MD, PhD	Stockholm CF Center, Karolinska University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stockholm CF Center, KArolinska University Hospital		Stockholm		14186	Sweden

Condition Browse Module

MeSH Terms

ID	Term
D003550	Cystic Fibrosis
D006506	Hepatitis A
D006509	Hepatitis B
D014376	Tuberculosis

Ancestor Terms

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014611	Vaccination
C433226	twinrix

Ancestor Terms

ID	Term
D016233	Immunotherapy, Active
D007114	Immunization
D007167	Immunotherapy
D056747	Immunomodulation

Browse Leaves

Not provided

Browse Branches

Not provided