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Miami, Florida

  • Growth Hormone Deficiency

Purpose:

The primary objective of this study is to determine the efficacy of 6 months of treatment with TV-1106 compared with placebo on body fat composition.


Criteria:

Inclusion: - males and females 18 years of age or over - diagnosis of adult growth hormone deficiency (GHD) for at least 6 months, or patients who have hypopituitarism from surgical resection - no history of exposure to any rhGH within the past 12 months prior to screening - stable, adequate doses of replacement hormones (adrenal, thyroid, estrogen, testosterone, vasopressin) for at least 3 months prior to screening - Other criteria apply, please contact the investigator for more information Exclusion: - patients with acute or chronic conditions or diseases that could confound results of the study or put the patient at undue risk as determined by the investigator - Presence of contraindications to rhGH treatment - patients who have participated in another clinical trial with a new chemical/biological entity within 3 months of screening - patients with known active malignancy (excluding surgically removed basal cell carcinoma or carcinoma in situ of cervix) - patients with a previously treated pituitary tumor with evidence of tumor progression in the past year patients with a new diagnosis of pituitary adenoma or other intracranial tumor within 12 months of screening - presence of Prader-Willi syndrome, Turner's syndrome, untreated adrenal insufficiency, active acromegaly in the past 5 years, or active Cushing's syndrome in the past 1 year - patients with type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus as indicated by a glycated hemoglobin (HBA1c) of ≥8% - patients using weight reducing agents or appetite suppressants - women who are pregnant or nursing, or planning pregnancy during the study period - Other criteria apply, please contact the investigator for more information


Study is Available At:


Original ID:

TV1106-IMM-30021


NCT ID:

NCT02410343


Secondary ID:

2014-003796-32


Study Acronym:


Brief Title:

Study of TV-1106 in Growth Hormone-Deficient Adults


Official Title:

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy, Safety, and Tolerability Study of TV-1106 in Growth Hormone-Deficient Adults Who Are Not Current Users of rhGH Treatment


Overall Status:

Terminated


Study Phase:

Phase 3


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Teva Pharmaceutical Industries


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:

Business decision


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

14


Enrollment Type:

Actual


Overall Contact Information

Official Name:Teva Medical Expert, MD
Study Director
Teva Pharmaceuticals USA

Study Dates

Start Date:April 2015
Completion Date:December 2015
Completion Type:Actual
Primary Completion Date:December 2015
Primary Completion Type:Actual
Verification Date:June 2018
Last Changed Date:June 8, 2018
First Received Date:March 30, 2015
First Results Date:May 10, 2018

Study Outcomes

Outcome Type:Primary Outcome
Measure:Body Fat Mass at Baseline, Week 24 and Endpoint in Core Period
Time Frame:Baseline (Day 1, pre-dose), Week 24, Endpoint in Core Period (post-baseline value prior to Week 24)
Safety Issues:False
Description:The primary efficacy measure for the study was body fat mass (kg) measured by DXA imaging. The primary outcome as defined in the protocol was the change from baseline to week 24 in body fat mass. Due to the early termination of the study, endpoint values
Outcome Type:Secondary Outcome
Measure:Total Trunk Fat at Baseline, Week 24 and Endpoint in Core Period
Time Frame:Baseline (Day 1, pre-dose), Week 24, Endpoint in Core Period (last post-baseline value prior to Week
Safety Issues:False
Description:Trunk fat (kg) was assessed based on DXA results. Trunk fat was defined as fat mass - (total arm fat + total leg fat + total head fat). The outcome as defined in the protocol was the within-patient change from baseline to week 24 in trunk fat. Due to the
Outcome Type:Secondary Outcome
Measure:Insulin-Like Growth Factor 1 Standard Deviation Score (IGF-I SDS) at Baseline, Week 24 and Endpoint in Core Period
Time Frame:Baseline (Day 1, pre-dose), Week 24, Endpoint in Core Period (last post-baseline value prior to Week
Safety Issues:False
Description:IGF-I SDS, as reported by the central laboratory, was a key secondary variable. The week 24 value is a trough value as it was taken 7 days after the last TV-1106 or placebo injection. The outcome as defined in the protocol was the within-patient change f
Outcome Type:Secondary Outcome
Measure:Scored Analysis of Quality of Life Assessment of GH Deficiency in Adults (QoL-AGHDA) at Baseline, Week 24 and Endpoint in Core Period
Time Frame:Baseline (Day 1, pre-dose), Week 24, Endpoint in Core Period (last post-baseline value prior to Week
Safety Issues:False
Description:The AGHDA instrument is comprised of 25 questions, with yes or no answers. To each of the 25 questions comprising QOL AGHDA, a score of 1 was assigned if the answer was affirmative and 0 if the answer was negative. Data reported is the total score across
Outcome Type:Secondary Outcome
Measure:Participants With Adverse Events During the Core Period
Time Frame:Day 1 up to 24 Weeks
Safety Issues:False
Description:An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a
Outcome Type:Secondary Outcome
Measure:Participants With Potentially Clinically Significant Abnormal Blood and Urine Test Results
Time Frame:Day 1 up to 24 Weeks
Safety Issues:False
Description:Parameters with potentially clinically significant abnormal test results include Serum chemistry: blood urea nitrogen, creatinine and bilirubin Hematology: leukocytes, hemoglobin, hematocrit, platelets and neutrophils Urinalysis: none Significance crit
Outcome Type:Secondary Outcome
Measure:Shift From Baseline To Endpoint in Core Period in Electrocardiogram Findings
Time Frame:Baseline (Day 1, pre-dose), Endpoint (up to Week 24)
Safety Issues:False
Description:Shifts represented as baseline - endpoint value (last observed post-baseline value). Abnormal NCS indicates an abnormal but not clinically significant finding. Abnormal CS indicates an abnormal and clinically significant finding.
Outcome Type:Secondary Outcome
Measure:Thyroid Stimulating Hormone (TSH) at Baseline and Endpoint
Time Frame:Baseline (Day 1, pre-dose), Endpoint (up to Week 24)
Safety Issues:False
Description:One measure of changes in replacement hormones. Endpoint values are the last observed post-baseline value in the Core Period.
Outcome Type:Secondary Outcome
Measure:Free Thyroxin (Free T4) at Baseline and Endpoint
Time Frame:Baseline (Day 1, pre-dose), Endpoint (up to Week 24)
Safety Issues:False
Description:One measure of changes in replacement hormones. Endpoint values are the last observed post-baseline value in the Core Period.
Outcome Type:Secondary Outcome
Measure:Triiodothyronine (Total T3) at Baseline and Endpoint
Time Frame:Baseline (Day 1, pre-dose), Endpoint (up to Week 24)
Safety Issues:False
Description:One measure of changes in replacement hormones. Endpoint values are the last observed post-baseline value in the Core Period.
Outcome Type:Secondary Outcome
Measure:Glycated Hemoglobin (HbA1c) at Baseline and Endpoint
Time Frame:Baseline (Day 1, pre-dose), Endpoint (up to Week 24)
Safety Issues:False
Description:One measure of glucose homeostasis. Endpoint values are the last observed post-baseline value in the Core Period.
Outcome Type:Secondary Outcome
Measure:Fasting Blood Glucose at Baseline and Endpoint
Time Frame:Baseline (Day 1, pre-dose), Endpoint (up to Week 24)
Safety Issues:False
Description:One measure of glucose homeostasis. Endpoint values are the last observed post-baseline value in the Core Period.
Outcome Type:Secondary Outcome
Measure:Insulin at Baseline and Endpoint
Time Frame:Baseline (Day 1, pre-dose), Endpoint (up to Week 24)
Safety Issues:False
Description:One measure of glucose homeostasis. Endpoint values are the last observed post-baseline value in the Core Period.
Outcome Type:Secondary Outcome
Measure:Local Tolerability Assessed by Injection Site Reactions
Time Frame:Day 1 up to Week 24
Safety Issues:False
Description:Participants reporting at least one injection site reaction.
Outcome Type:Secondary Outcome
Measure:Pharmacokinetic Serum Concentration of TV1106 by Nominal Sampling Timepoints
Time Frame:Baseline (Day 1, pre-dose), Weeks 4, 8, 12, 16, 24
Safety Issues:False
Description:Weeks 4 and 8 serum samples obtained 2 days after TV1106 administration. Weeks 12 and 24 serum samples obtained 7 days after TV1106 administration. Week 16 serum samples obtained 1 day after TV1106 administration.

Study Interventions

Intervention Type:Drug
Name:TV-1106
Description:A starting dose of 5.0 mg was expected to be appropriate for most patients because the daily recommended starting dose of recombinant human growth hormone (rhGH) treatments (e.g. somatropin) is 0.2 mg/day, and the conversion factor was 28. Dosage could be titrated by an unblinded central reader on weeks 4, 8, 12 and 16 until the participant's insulin-like growth factor 1 (IGF-1) standard deviation score (SDS) was within the range of -0.5 to +1.5.
Arm Name:TV-1106
Other Name:long-acting growth hormone, albutropin
Intervention Type:Drug
Name:Placebo
Description:Placebo treatment was administered in a blinded fashion and titrated on weeks 4, 8, 12 and 16 to mimic the active treatment.
Arm Name:Placebo
Other Name:Matching placebo

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description:Placebo was injected subcutaneously once weekly on the same day and time for 24 weeks. To maintain the blind, placebo could be titrated by an unblinded central reader on weeks 4, 8, 12 and 16 to match the effect of dose titration.
Study Arm Type:Experimental
Arm Name:TV-1106
Description:TV-1106 was injected subcutaneously once weekly on the same day and time for 24 weeks. A common starting dose was 5.0 mg. Doses could be titrated by an unblinded central reader on weeks 4, 8, 12 and 16 until the participant's insulin-like growth factor 1 (IGF-1) standard deviation score (SDS) was within the range of -0.5 to +1.5.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Teva Pharmaceutical Industries, Ltd.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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