Trial Details
Not RecruitingBasic Information
| Clinical ID | c3228 |
|---|---|
| Identifier | EUCTR2010-022215-19-GB |
| Trial Title | A Pharmacokinetic Study Of The Combined Use Of Recombinant Human GH And IGF-1 In Children With Inflammatory Bowel (Crohn) Disease __ - Combination rhGH + rhIGF-1 in childhood/adolescent Crohn |
| Trial URL | Visit Original Page |
Study Information
| Study Results | No results available |
|---|---|
| Conditions | Impaired growth in Paediatric Crohn's disease MedDRA version: 14.1_Level: LLT_Classification code 10011398_Term: Crohn's_System Organ Class: 100000004856_;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] |
| Interventions | Trade Name: Increlex Product Name: Increlex 10mg/ml solution for injection Pharmaceutical Form: Solution for injection INN or Proposed INN: Mecasermin [rDNA Origin] 10mg/ml solution CAS Number: 67763-96-6 Other descriptive name: Recombinant human Insulin-like Growth Factor Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Trade Name: NutropinAq Product Name: NutropinAq 10mg/2ml solution for injection Pharmaceutical Form: Solution for injection INN or Proposed INN: Somatropin(rhGH) CAS Number: 12629-01-5 Other descriptive name: recombinant growth hormone Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5-1 |
Participant Information
| Sponsor | Greater Glasgow & Clyde NHS |
|---|---|
| City | - |
| Country/Region | United Kingdom |
Enrollment Criteria
| Sex Requirement | NOT SPECIFIED |
|---|---|
| Age Requirement | - |
Study Design
| Study Type | Interventional clinical trial of medicinal product |
|---|---|
| Phase | PHASE2 |
Time Information
| Start Date | 2025-04-24 |
|---|---|
| Primary Completion Date | - |
| Completion Date | - |