NCT00737113

Recombinant Human Growth Hormone (RH-GH) For Accelerating Immune Reconstitution Post Unrelated Cord Blood Transplant

Recombinant Human Growth Hormone(RH-GH) For Accelerating Immune Reconstitution In Pediatric and Adult Patients Undergoing Allogeneic Stem Cell Transplantation

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Mitchell Horwitz, MD · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to define the safety and efficacy of recombinant human growth hormone (rh-GH, Genotropin) in a patients undergoing allogeneic transplantation.

Detailed description

The primary objective of this study is to define the safety and efficacy of recombinant human growth hormone (rh-GH, Genotropin) in a population of patients undergoing allogeneic stem cell transplant. The secondary objectives of this study are: to evaluate the incidence of mortality due to opportunistic infections in the first 6 months, to evaluate the incidence and severity of infectious complications, to assess laboratory parameters of post-transplant immune recovery in patients on GH therapy and to determine the probability and time of neutrophil and platelet recovery on GH therapy.

Conditions

• Allogeneic Stem Cell Transplantation

Interventions

Type	Name	Description
DRUG	Genotropin (Recombinant Human Growth Hormone)	Patients will begin daily subcutaneous (SC) therapy at a starting dose of \~0.02mg/kg body weight. The study drug will continue for 90 days post enrollment.

Timeline

• Start date: 2008-09-01
• Primary completion: 2012-05-01
• Completion: 2013-12-01
• First posted: 2008-08-18
• Last updated: 2014-03-20

Locations

1 site across 1 country: United States