Phase 2 Study of PEG-Intron in Hereditary Hemorrhagic Telangiectasia

This study has been terminated.
(Schering-Plough discontinued supplying study drug.)
Sponsor:
Collaborators:
Georgia Regents University
St. Michael's Hospital, Toronto
Schering-Plough
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00588146
First received: December 26, 2007
Last updated: February 19, 2013
Last verified: February 2013
Results First Received: December 20, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Anemia
Liver Disease
Hypoxemia
Interventions: Drug: Pegylated Interferon Alpha2b
Other: Standard care

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from Mayo Clinic, Rochester, Minnesota from January 2007 through September 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Pegylated Interferon Alpha2b, Then Standard Care Weekly subcutaneous injection of pegylated interferon alpha2b 1 microgram/kg/week for 6 months, then standard care for 6 months.
Standard Care, Then Pegylated Interferon Alpha2b Standard care for 6 months, then weekly subcutaneous injection of pegylated interferon alpha2b 1 microgram/kg/week for 6 months.

Participant Flow for 2 periods

Period 1:   First Intervention (Baseline to 6 mo)
    Pegylated Interferon Alpha2b, Then Standard Care     Standard Care, Then Pegylated Interferon Alpha2b  
STARTED     5     5  
COMPLETED     1     2  
NOT COMPLETED     4     3  
Adverse Event                 4                 3  

Period 2:   Second Intervention (6 Months to 1 Year)
    Pegylated Interferon Alpha2b, Then Standard Care     Standard Care, Then Pegylated Interferon Alpha2b  
STARTED     1     2  
COMPLETED     1     2  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Entire Study Population Includes groups randomized to pegylated interferon alpha-2b first and standard care first.

Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
  10  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     6  
>=65 years     4  
Age  
[units: years]
Mean ± Standard Deviation
  56  ± 15.8  
Gender  
[units: participants]
 
Female     8  
Male     2  
Region of Enrollment  
[units: participants]
 
United States     10  



  Outcome Measures

1.  Primary:   Change in Hemoglobin   [ Time Frame: baseline, one year ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was terminated early because Schering-Plough discontinued supplying study drug.  


Results Point of Contact:  
Name/Title: Karen L. Swanson, D.O.
Organization: Mayo Clinic
phone: 507-255-3214
e-mail: swanson.karen@mayo.edu


No publications provided


Responsible Party: Karen Swanson, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00588146     History of Changes
Other Study ID Numbers: 2400-05, R01FD003076-01
Study First Received: December 26, 2007
Results First Received: December 20, 2012
Last Updated: February 19, 2013
Health Authority: United States: Food and Drug Administration