Trial of Growth Hormone Therapy in Pediatric Crohn's Disease - Full Text View

Sponsors and Collaborators:	Children's Hospital Medical Center, Cincinnati Genentech
Information provided by:	Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:	NCT00109473

Purpose

The purpose of this study is to determine whether taking a growth hormone (GH) drug called somatropin causes the intestine of a person with Crohn's Disease (CD) to heal faster when compared to a person with Crohn's Disease that does not receive growth hormone drug.

Condition	Intervention	Phase
Crohn's Disease	Drug: Somatropin, E-coli Derived	Phase II

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Insulin-like growth factor I Mecasermin rinfabate Somatotropin Somatropin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Phase II Randomized Trial of Growth Hormone Therapy in Pediatric Crohn's Disease

Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:

The primary endpoint will be the CD histologic index of severity (CDHIS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Serum IGF-1 [ Time Frame: Throughout study duration when interventional drug is administered ] [ Designated as safety issue: Yes ]
Colon crypt epithelial cell (CEC) proliferation labeling index [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
IMPACT III [ Time Frame: At 12 and 64 weeks, and yearly on maintenance phase ] [ Designated as safety issue: No ]
Pediatric Crohn's disease Activity Index [ Time Frame: At 12 and 64 weeks, then yearly in maintenance phase ] [ Designated as safety issue: No ]
Total corticosteroid use [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Intra-abdominal fat [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Height velocity [ Time Frame: 64 weeks ] [ Designated as safety issue: No ]
Fecal Calprotectin [ Time Frame: At 24 and 64 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	28
Study Start Date:	April 2005
Estimated Study Completion Date:	May 2011
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Intervention Details:

0.075 mg/kg/day SC daily, for subjects post pubertal the maximum dose during will be 5 mg daily. Dose may be modified due to drug attributable adverse events and IGF-1 levels

Detailed Description:

The optimal treatment goals in childhood CD include: 1) clinical remission in conjunction with mucosal healing and 2) restoration of normal growth and development. Current therapy in most cases includes induction of remission with corticosteroids followed by maintenance of remission with 6-mercaptopurine (6-MP) or mesalamine. With this approach, the goals of achieving mucosal healing with normalization of growth are not achieved in a significant number of children. GH therapy is now used in several chronic childhood diseases which are complicated by growth failure despite adequate GH secretion. These include chronic renal failure (CRF), juvenile rheumatoid arthritis (JRA), and Turner's syndrome. However, despite a comparable frequency and magnitude of permanent growth failure, the efficacy of GH therapy in this respect has not yet been determined in a controlled trial for CD. Moreover, whether GH therapy may also directly reduce disease activity and promote intestinal healing is not known. This represents a significant clinically unmet need in this patient population. Therefore, new therapeutic approaches are needed to both improve final adult height and enhance intestinal mucosal healing in children with CD.

The primary objective of this study is to determine the effect of growth hormone (GH) therapy upon colon mucosal healing in a 12 week randomized trial in children with Crohn's Disease (CD). Children with active CD will be randomized to GH + prednisone (GP) or prednisone alone (P) for a 12 week period. This study also involves a 52 week extension phase where all participants that meet eligibility will be given the opportunity to take or continue taking growth hormone for 52 weeks.

Eligibility

Ages Eligible for Study:	5 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Ability to provide written informed consent
Age ≥ 5 years.
Diagnosis of Crohn's disease (CD) with ileo-colonic involvement as determined by standard clinical, radiological, and pathological criteria.
Moderate to severely active CD as defined by a PCDAI (Pediatric Crohn's Disease Activity Index) ≥ 30.
Currently taking Prednisone or Budesonide at starting dose (not tapering)
May continue stable doses of AZA/6-MP, methotrexate, and/or mesalamine at entry.
For the 52 week extension, baseline bone age ≤ 12 years for girls and ≤ 13 years for boys.
For the 52 week extension phase, remission or mild Crohn's disease as determined by a PCDAI < 30.

Exclusion Criteria:

Acute critical illness
Active neoplasia
Diabetes mellitus
History of intracranial lesion and/or neoplasia
Severe disease requiring hospitalization for treatment
Current therapy with infliximab as this may independently rapidly reduce clinical disease activity and promote mucosal healing
Use of prednisone or budesonide and in tapering phase
Family history of colorectal cancer before age 50
Personal or familial history of familial polyposis syndrome
Pregnancy (positive pregnancy test) prior to randomization
Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
Participation in another simultaneous medical investigation or trial other than the Pediatric IBD (Inflammatory Bowel Disease) registry

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00109473

Locations

United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229

Sponsors and Collaborators

Children's Hospital Medical Center, Cincinnati

Genentech

Investigators

Principal Investigator:

Lee Denson, M.D.

Children's Hospital Medical Center, Cincinnati

More Information

Responsible Party:	Cincinnati Children's Hospital Medical Center ( Dr. Lee Denson )
Study ID Numbers:	CCHMC IRB #: 04-12-06, FDA IND#: 71344
Study First Received:	April 28, 2005
Last Updated:	May 22, 2008
ClinicalTrials.gov Identifier:	NCT00109473
Health Authority:	United States: Food and Drug Administration

Keywords provided by Children's Hospital Medical Center, Cincinnati:

Pediatric Crohn's disease
Pediatric
Crohn's Disease

Study placed in the following topic categories:

Digestive System Diseases
Crohn’s disease, pediatric
Gastrointestinal Diseases
Crohn Disease

Inflammatory Bowel Diseases
Gastroenteritis
Intestinal Diseases

ClinicalTrials.gov processed this record on January 15, 2009