Trial of Growth Hormone Therapy in Pediatric Crohn's Disease

NCT00109473 | Completed Phase 2 Results DMC

• 2 other identifiers: CCHMC IRB #: 04-12-06IND # 71,344
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn's Disease

Keywords

Pediatric Crohn's disease; Pediatric; Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• Crohn's Disease Histologic Index of Severity (CDHIS)

  The CDHIS was developed and validated in order to determine the effect of therapies upon histologic disease activity in Crohn's Disease. It has been used to assess mucosal healing in response to infliximab and 6-MP/AZA.It contains eight items which reflect epithelial injury, mucosal inflammation, and the extent of involvement. Scores range from 0-16, with patients with moderate to severely active CD typically having scores of 6-12. It was computed by a GI pathologist. The higher the score indicates worsening of disease, the lowest score is 0 and highest possible is 16

  Baseline and 12 weeks

Secondary Outcomes (7)

• Serum IGF-1 (Insulin-like Growth Factor 1)z Score

  Baseline, 12 weeks, 24 weeks

• IMPACT III Score

  Baseline, 12 weeks, 24 weeks

• Pediatric Crohn's Disease Activity Index (PCDAI)

  Baseline, 12 and 24 weeks

• Total Corticosteroid Use

  12 weeks

• Crohn's Disease Endoscopic Index of Severity (CDEIS)

  Baseline and 12 weeks

Study Arms (2)

Growth Hormone plus cortecosteroid

EXPERIMENTAL

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

Drug: growth hormone

Cortecosteroids alone

ACTIVE COMPARATOR

Cortecosteroid therapy as prescribed by the referring gastroenterologist

Drug: cortecosteroid

Interventions

growth hormone DRUG

Nutropin AQ 0.075mg/kg/day subcutaneously daily

Also known as: Nutropin AQ

Growth Hormone plus cortecosteroid

cortecosteroid DRUG

As prescribed by the referring gastroenterologist

Also known as: Prednisone, Entocort

Cortecosteroids alone

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Crohn Disease; Pediatric Crohn's disease

Interventions

Growth Hormone; Prednisone; Budesonide

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnenediones; Pregnenes

Results Point of Contact

• Title: Lee A. Denson
• Organization: Cincinnati Children's Hospital Medical Center

lee.denson@cchmc.org

513-636-7575

Study Officials

• Lee Denson, M.D.

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2005
• First Posted: April 29, 2005
• Study Start: April 1, 2005
• Primary Completion: July 1, 2009
• Study Completion: August 1, 2009
• Last Updated: October 30, 2020
• Results First Posted: September 16, 2011

Record last verified: 2020-10

Locations

US (1)