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RELAX: Real-world Evidence Study EvaLuating PAtient-Reported Outcomes With XERMELO

Sponsor
TerSera Therapeutics LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT03223428
Collaborator
(none)
349
Enrollment
1
Location
54.8
Actual Duration (Months)
6.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of the study is to estimate the proportion of carcinoid syndrome (CS) patients who are satisfied with their overall symptom control, 6 months after initiating treatment with telotristat ethyl (XERMELO).

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
349 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
An Observational Study to Evaluate the Real-world Experience of Patients Who Are Initiating Treatment With Telotristat Ethyl (XERMELO™)
Actual Study Start Date :
Jun 22, 2017
Actual Primary Completion Date :
Jan 14, 2022
Actual Study Completion Date :
Jan 14, 2022

Arms and Interventions

Arm Intervention/Treatment
Carcinoid Syndrome patients initiating Xermelo

Patients with Carcinoid Syndrome who are initiating treatment with XERMELO.

Drug: Xermelo
This study will include patients with carcinoid syndrome who are initiating treatment with XERMELO.
Other Names:
  • Telotristat ethyl

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of patients who are satisfied with their overall symptom control [6 months]

      The proportion of CS patients who are satisfied with their overall symptom control, 6 months after initiating treatment with telotristat ethyl (XERMELO).

    Secondary Outcome Measures

    1. Proportion of patients reporting satisfaction of CS-related diarrhea control [6 months]

      Estimate proportion of patients reporting satisfaction with CS-related diarrhea control

    2. Proportion of patients reporting satisfaction of CS- related flushing control [6 months]

      Estimate proportion of patients reporting satisfaction with CS-related flushing control

    3. Proportion of patients reporting reduction in rescue somatostatin analog (SSA) use [6 months]

      Estimate proportion of patients reporting reduction in rescue SSA use

    4. Proportion of patients reporting reduction in the dose of long-acting SSA injection [6 months]

      Estimate proportion of patients reporting reduction in the dose of long-acting SSA injection

    5. Proportion of patients reporting reduction in the frequency of long-acting SSA injection [6 months]

      Estimate proportion of patients reporting reduction in frequency of long-acting SSA injection

    6. Proportion of patients reporting an overall improvement in CS control after initiating XERMELO based on patient global impression of change (PGIC) [6 months]

      Estimate proportion of patients reporting an overall improvement in CS control after initiating Xermelo based on PGIC

    7. Proportion of patients that had reduction in in work-related absenteeism, presenteeism, activity impairment, and overall productivity loss based on Worker Productivity and Activity Impairment: Specific Health Problem v2.0 (WPAI- SHP) [6 months]

      Estimate the proportion of patients that had reduction in work-related absenteeism, presenteeism, activity impairment, and overall productivity loss after initiating telotristat ethyl based on WPAI-SHP

    8. Proportion of patients reporting weight gain [6 months]

      Estimate the proportion of patients reporting weight gain

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • Adult, ≥18 years of age at the time of informed consent

    • A new, valid prescription for XERMELO

    • Initiating XERMELO for the treatment of carcinoid syndrome

    • Able and willing to provide informed consent prior to participation in the study

    Exclusion Criteria:

    • Unable to understand and read English

    • Unable to access the internet

    • Prior exposure to XERMELO

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 RTI-HS Research Triangle Park North Carolina United States 27709

    Sponsors and Collaborators

    • TerSera Therapeutics LLC

    Investigators

    • Study Director: Lonnie Brent, PhD, TerSera Therapeutics

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    TerSera Therapeutics LLC
    ClinicalTrials.gov Identifier:
    NCT03223428
    Other Study ID Numbers:
    • LX1606.1-401-CS
    • LX1606.401
    First Posted:
    Jul 21, 2017
    Last Update Posted:
    Feb 2, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Additional relevant MeSH terms:
    Malignant Carcinoid Syndrome
    Serotonin Syndrome

    Study Results

    No Results Posted as of Feb 2, 2022