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Study was terminated early due to low accrual.
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genotropin (Recombinant Human Growth Hormone) | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To define the safety of recombinant human growth hormone (rh-GH, Genotropin) in a population of patients undergoing allogeneic transplantation | After 6, 12, 18 patients have enrolled |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the incidence of mortality due to opportunistic infections in the first 6 months. | After 6, 12, and 18 patients have enrolled | |
| To evaluate the incidence and severity of infectious complications. | After 6, 12, and 18 patients have enrolled |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mitchell Horwitz, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
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| ID | Term |
|---|---|
| D019382 | Human Growth Hormone |
| D013006 | Growth Hormone |
| ID | Term |
|---|---|
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| To assess laboratory parameters of post-transplant immune recovery in patients on GH therapy. | After 6, 12, and 18 patients enroll. |
| To determine the probability and time of neutrophil and platelet recovery on GH therapy. | After 6, 12, and 18 patients enroll |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |