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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00737113
Recruitment Status : Terminated (Study was terminated early due to low accrual.)
First Posted : August 18, 2008
Last Update Posted : March 20, 2014
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Mitchell Horwitz, MD, Duke University

Tracking Information
First Submitted Date  ICMJE August 15, 2008
First Posted Date  ICMJE August 18, 2008
Last Update Posted Date March 20, 2014
Study Start Date  ICMJE September 2008
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2010)
To define the safety of recombinant human growth hormone (rh-GH, Genotropin) in a population of patients undergoing allogeneic transplantation [ Time Frame: After 6, 12, 18 patients have enrolled ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 15, 2008)
To define the safety of recombinant human growth hormone (rh-GH, Genotropin) in a population of patients undergoing unrelated cord blood transplantation [ Time Frame: After 6, 12, 18 patients have enrolled ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2008)
  • To evaluate the incidence of mortality due to opportunistic infections in the first 6 months. [ Time Frame: After 6, 12, and 18 patients have enrolled ]
  • To evaluate the incidence and severity of infectious complications. [ Time Frame: After 6, 12, and 18 patients have enrolled ]
  • To assess laboratory parameters of post-transplant immune recovery in patients on GH therapy. [ Time Frame: After 6, 12, and 18 patients enroll. ]
  • To determine the probability and time of neutrophil and platelet recovery on GH therapy. [ Time Frame: After 6, 12, and 18 patients enroll ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Recombinant Human Growth Hormone (RH-GH) For Accelerating Immune Reconstitution Post Unrelated Cord Blood Transplant
Official Title  ICMJE Recombinant Human Growth Hormone(RH-GH) For Accelerating Immune Reconstitution In Pediatric and Adult Patients Undergoing Allogeneic Stem Cell Transplantation
Brief 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Allogeneic Stem Cell Transplantation
Intervention  ICMJE 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.
Other Names:
  • rh-GH
  • Genotropin
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 7, 2012)
14
Original Estimated Enrollment  ICMJE
 (submitted: August 15, 2008)
18
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥12
  • <90 days following Allogeneic Transplantation.
  • ANC>500/ul for 3 consecutive days.
  • ≥50% donor cells in all cellular fractions tested.
  • No active grade II or higher acute graft versus host disease
  • Receiving ≤ 1 mg/kg/day Methylprednisolone or equivalent
  • Documentation of morphologic or radiographic remission within 45 days of protocol enrollment

Exclusion Criteria:

  • Patients with acute organ dysfunction requiring monitoring in the Intensive Care unit or receiving invasive interventions that may include, Hemodialysis ,CVVHD, or any form of mechanical ventilation including CPAP/BiPap at the time of starting therapy.
  • Pregnant or lactating patients and those without a negative pregnancy test.
  • Patients must have a life expectancy of at least 3 months.
  • Patients must be HIV negative.
  • Patients must not be receiving investigational agents for treatment of GVHD.
  • Patients with severe veno-occlusive disease as determined by standard criteria.
  • Patients with Type 1 Diabetes at the time of initiation of stem cell transplantation.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00737113
Other Study ID Numbers  ICMJE Pro00001910
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mitchell Horwitz, MD, Duke University
Study Sponsor  ICMJE Mitchell Horwitz, MD
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Mitchell Horwitz, MD Duke University
PRS Account Duke University
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP