|
Main
|
|
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:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 October 2017 |
|
Main ID: |
NCT00325078 |
|
Date of registration:
|
11/05/2006 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Infliximab to Treat Crohn'S-like Inflammatory Bowel Disease in Chronic Granulomatous Disease
|
|
Scientific title:
|
Tumor Necrosis Factor Alpha Inhibitor (Lnfliximab, Adalimumab) Treatment for Crohn'S-like Inflammatory Bowel Disease in Chronic Granulomatous Disease: A Phase I/II Study Assessing Clinical and Immune Responses to Treatment and Genetic Influences |
|
Date of first enrolment:
|
May 2006 |
|
Target sample size:
|
40 |
|
Recruitment status: |
Terminated |
|
URL:
|
https://clinicaltrials.gov/show/NCT00325078 |
|
Study type:
|
Interventional |
|
Study design:
|
|
|
Phase:
|
Phase 1/Phase 2
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Suk S De Ravin, M.D. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
National Institute of Allergy and Infectious Diseases (NIAID) |
| | |
|
Key inclusion & exclusion criteria
|
- INCLUSION CRITERIA:
Group One
- Must have a confirmed CGD diagnosis
- Must have IBD documented by medical history or documented IBD endoscopically.
- Must not be pregnant or breastfeeding
- Must have a home physician
- Must be willing to submit samples for storage.
Group Two:
- Must have a confirmed CGD diagnosis
- Must have IBD documented by medical history or documented IBD endoscopically.
- Must be symptomatic
- Must have negative results on stool examination for culture of enteric pathogens, such
as Salmonella, Shigella, Yersinia, Campylobacter, E. coli O157/H7, Clostridium
difficile toxin assay, enteric parasites and their ova such as Cryptosporidia,
Cyclospora, Microsporidia and Giardia (by stool enzyme immunoassay [EIA]) prior to the
start of receiving TNF? inhibitors.
- Must not be pregnant or breastfeeding
- If of childbearing potential, one must agree to consistently use contraception, while
on the study medication.
- Must have a recent chest CT (within 3 months) to confirm absence of tuberculosis (TB)
infection
- Must have a home physician
- Must be willing to submit samples for storage.
Group Three:
- Must be willing to undergo upper and lower endoscopy and mucosal biopsies for research
purpose
- Must be greater than or equal to 18 years old and weigh greater than or equal to 15
kg.
- Must not be pregnant
- Must be willing to submit samples for storage.
EXCLUSION CRITERIA:
Group One:
- Any condition that, in the investigator's opinion, places the patient at undue risk by
participating in the study.
Group Two:
- Any condition that, in the investigator's opinion, places the patient at undue risk by
participating in the study
- Positive TB diagnosis
- Patients who are in the at-risk group for treatment such as history of tuberculosis,
congestive cardiac failure or myocardial infarction within the last 12 months unstable
angina, thrombocytopenia (platelet < 100, 000), uncontrolled hypertension
- Acute systemic or intestinal infection(s)
- Evidence of Hepatitis B or C infection
- Signs and symptoms of hepatotoxicity
- Pregnant or breastfeeding
- History of cancer within the last 10 years
- The presence of certain types of acquired abnormalities of immunity such as HIV,
cytotoxic chemotherapy for malignancy could be grounds for possible exclusion if, in
the opinion of the investigator, the presence of such disease process interferes with
evaluation of a co-existing abnormality of immunity that is a subject of study under
this protocol.
- Co-existing Th2-type inflammatory disease
- Current active bowel obstruction, intestinal perforation, or significant GI
hemorrhage.
- Live vaccine within 4 weeks prior to therapy or potential need for a live vaccine
during the study.
- Unwillingness to undergo testing or procedures associated with this protocol.
Group Three:
- Acute systemic or intestinal infection requiring antibiotics
- Any condition that, in the investigator's opinion, places the patient at undue risk by
participating in the study
- The presence of certain types of acquired abnormalities of immunity such as HIV,
cytotoxic chemotherapy for malignancy could be grounds for possible exclusion if, in
the opinion of the investigator, the presence of such disease process interferes with
evaluation of a co-existing abnormality of immunity that is a subject of study under
this protocol.
- Unwillingness to undergo testing or procedures associated with this protocol.
Age minimum:
10 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Crohn'S-like IBD
|
|
Chronic Granulomatous Disease
|
|
Inflammatory Bowel Disease (IBD)
|
|
Intervention(s)
|
|
Drug: Infliximab
|
|
Primary Outcome(s)
|
|
Efficacy of Treatment With Study Drug
[Time Frame: Baseline, 1 year]
|
|
Safety of Study Drug
[Time Frame: Baseline to 1 year]
|
|
Secondary ID(s)
|
|
06-I-0160
|
|
060160
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|