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Not recruiting

Pharmacogenomics

Sponsor:

University of British Columbia

Code:

NCT01118130

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

To investigate whether genotypic differences can be identified between MS patients developing 'liver injury' (defined as ALT levels five times the upper normal limit and above) compared to those not developing liver injury after exposure to beta-interferon for MS.

Conditions

Multiple Sclerosis

Study ID

NCT01118130

Start date

Jun, 2010

Status verified date

May, 2024

Completion date

May, 2025

Anticipated

Primary completion date

May, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria: Cases and controls must have

  • definite MS (Poser or McDonald criteria)
  • relapsing-remitting or secondary-progressive disease course
  • Prescribed a beta-interferon as their immunomodulatory drug for MS

Exclusion Criteria:

  • primary-progressive MS
  • an elevated liver test result within 6 months of starting beta-interferon treatment
  • presence of a co-morbidity that is a known risk-factor for liver injury

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Case

MS patients experiencing an adverse drug reaction to an MS immunomodulatory therapy

Control

MS patients not experiencing an adverse drug reaction to an MS immunomodulatory therapy

Primary outcome measure

  • Experienced an adverse drug reaction or not? [ Time Frame: No specified time frame ]

Central Contacts and Locations

Central contacts

Bruce Carleton, PharmD

604-875-2179bcarleton@popi.ubc.ca

Locations

MS Clinic UBC Hospital

Recruiting

Vancouver, British Columbia, Canada, V6T 2B5

More Information

Sponsor

University of British Columbia

Last update posted

May 8, 2024

Last verified

May, 2024

Keywords

  • Genetics
  • genomics
  • Multiple Sclerosis
  • beta-interferons

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by University of British Columbia on 2024-05-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.