Trial of Growth Hormone Therapy in Pediatric Crohn's Disease

NCT ID: NCT00109473

Last Updated: 2020-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2009-08-31

Brief Summary

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.

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.

Conditions

Crohn's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Growth Hormone plus cortecosteroid

Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)

Group Type: EXPERIMENTAL

growth hormone

Intervention Type: DRUG

Nutropin AQ 0.075mg/kg/day subcutaneously daily

Cortecosteroids alone

Cortecosteroid therapy as prescribed by the referring gastroenterologist

Group Type: ACTIVE_COMPARATOR

cortecosteroid

Intervention Type: DRUG

As prescribed by the referring gastroenterologist

Interventions

growth hormone

Nutropin AQ 0.075mg/kg/day subcutaneously daily

Intervention Type: DRUG

cortecosteroid

As prescribed by the referring gastroenterologist

Intervention Type: DRUG

Other Intervention Names

Nutropin AQ; Prednisone, Entocort

Eligibility 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

• Minimum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lee Denson, M.D.

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

IND # 71,344

Identifier Type: OTHER

Identifier Source: secondary_id

CCHMC IRB #: 04-12-06

Identifier Type: -

Identifier Source: org_study_id