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Trial record 51 of 295 for:    IFNA2 AND PEG-interferon alfa-2b

Phase 2 Study of PEG-Intron in Hereditary Hemorrhagic Telangiectasia

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: NCT00588146
Recruitment Status : Terminated (Schering-Plough discontinued supplying study drug.)
First Posted : January 8, 2008
Results First Posted : January 28, 2013
Last Update Posted : February 22, 2013
Sponsor:
Collaborators:
Augusta University
St. Michael's Hospital, Toronto
Schering-Plough
Information provided by:
Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Anemia
Liver Disease
Hypoxemia
Interventions Drug: Pegylated Interferon Alpha2b
Other: Standard care
Enrollment 10
Recruitment Details Subjects were recruited from Mayo Clinic, Rochester, Minnesota from January 2007 through September 2010.
Pre-assignment Details  
Arm/Group Title Pegylated Interferon Alpha2b, Then Standard Care Standard Care, Then Pegylated Interferon Alpha2b
Hide Arm/Group Description Weekly subcutaneous injection of pegylated interferon alpha2b 1 microgram/kg/week for 6 months, then standard care for 6 months. Standard care for 6 months, then weekly subcutaneous injection of pegylated interferon alpha2b 1 microgram/kg/week for 6 months.
Period Title: First Intervention (Baseline to 6 mo)
Started 5 5
Completed 1 2
Not Completed 4 3
Reason Not Completed
Adverse Event             4             3
Period Title: Second Intervention (6 Months to 1 Year)
Started 1 2
Completed 1 2
Not Completed 0 0
Arm/Group Title Entire Study Population
Hide Arm/Group Description Includes groups randomized to pegylated interferon alpha-2b first and standard care first.
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
6
  60.0%
>=65 years
4
  40.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
56  (15.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
8
  80.0%
Male
2
  20.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
1.Primary Outcome
Title Change in Hemoglobin
Hide Description The hemoglobin level is expressed as the amount of hemoglobin in grams (gm) per deciliter (dL) of whole blood.
Time Frame baseline, one year
Hide Outcome Measure Data
Hide Analysis Population Description
Only 3 subjects completed the study, so the numbers were too low to analyze the study.
Arm/Group Title Pegylated Interferon Alpha2b, Then Standard Care Standard Care, Then Pegylated Interferon Alpha2b
Hide Arm/Group Description:
Weekly subcutaneous injection of pegylated interferon alpha2b 1 microgram/kg/week for 6 months, then standard care for 6 months.
Standard care for 6 months, then weekly subcutaneous injection of pegylated interferon alpha2b 1 microgram/kg/week for 6 months.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events were collected over the 1-year study by telephone or direct interview. Adverse events were graded according to Modified NCI Common Toxicity Criteria. If a subject discontinued for an adverse event, they were observed for 12 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pegylated Interferon Alpha-2b Standard Care
Hide Arm/Group Description Weekly subcutaneous injection of pegylated interferon alpha2b 1 microgram/kg/week Subjects received standard care for hereditary hemorrhagic telangiectasia.
All-Cause Mortality
Pegylated Interferon Alpha-2b Standard Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pegylated Interferon Alpha-2b Standard Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/10 (30.00%)      0/10 (0.00%)    
Blood and lymphatic system disorders     
Neutropenia   3/10 (30.00%)  3 0/10 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pegylated Interferon Alpha-2b Standard Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/10 (20.00%)      2/10 (20.00%)    
General disorders     
Seizure   0/10 (0.00%)  0 1/10 (10.00%)  1
Musculoskeletal and connective tissue disorders     
Myalgias   1/10 (10.00%)  1 1/10 (10.00%)  1
Arthralgias   1/10 (10.00%)  1 1/10 (10.00%)  1
Right flank pain   1/10 (10.00%)  1 0/10 (0.00%)  0
Psychiatric disorders     
Depression   0/10 (0.00%)  0 1/10 (10.00%)  2
Indicates events were collected by systematic assessment
The study was terminated early because Schering-Plough discontinued supplying study drug.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Karen L. Swanson, D.O.
Organization: Mayo Clinic
Phone: 507-255-3214
EMail: swanson.karen@mayo.edu
Layout table for additonal information
Responsible Party: Karen Swanson, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00588146     History of Changes
Other Study ID Numbers: 2400-05
R01FD003076-01 ( U.S. FDA Grant/Contract )
First Submitted: December 26, 2007
First Posted: January 8, 2008
Results First Submitted: December 20, 2012
Results First Posted: January 28, 2013
Last Update Posted: February 22, 2013