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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	13 October 2020
Main ID:	EUCTR2004-001261-17-IE
Date of registration:	08/12/2004
Prospective Registration:	Yes
Primary sponsor:	InterMune
Public title:	An Open-Label Study of the Safety of Subcutaneous Recombinant Interferon gamma-1b in Patients with Idiopathic Pulmonary Fibrosis
Scientific title:	An Open-Label Study of the Safety of Subcutaneous Recombinant Interferon gamma-1b in Patients with Idiopathic Pulmonary Fibrosis
Date of first enrolment:	28/01/2005
Target sample size:
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-001261-17
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
Phase:	Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment
Ireland

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:
Address:
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria:
1. Enrollment in Protocol GIPF-002 Part B or GIPF-004
2. Completion of the End of Treatment Visit in Protocol GIPF-002 Part B or the Study
Completion Visit in GIPF-004
3. Able to understand and sign a written informed consent form and comply with the
requirements of the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Pregnancy or lactation
2. Lack of adherence to GIPF-002 or GIPF-004 study protocol and treatment regimen
3. In the opinion of the Principal Investigator (PI), the patient is not a suitable candidate for study participation

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis (IPF)

Intervention(s)

Trade Name: Immukin
Product Name: Interferon gamma-1b
Pharmaceutical Form: Solution for injection

Primary Outcome(s)

Main Objective: To assess the long-term safety of subcutaneous IFN-g 1b, administered in doses of 200 mg three times per week (tiw) in patients who complete either InterMune Protocol GIPF-002 Part B or GIPF-004.

Secondary Objective: To provide access to IFN-g 1b for patients who have completed these studies.

Primary end point(s):

Secondary Outcome(s)

Secondary ID(s)

GIPF-006

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 24/06/2004
Contact:

Results

Results available:
Date Posted:
Date Completed:
URL:

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