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

TerSera Therapeutics LLC223 enrolled

Overview

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).

This study will evaluate patient-reported outcomes for adults initiating telotristat ethyl (XERMELO) for carcinoid syndrome diarrhea (CSD) not adequately controlled by somatostatin analogs in US clinical practice. The primary objective is satisfaction with overall CS symptom control 6 months after starting XERMELO. Secondary objectives will evaluate satisfaction with control of CSD and flushing, CS symptoms, work productivity and activity impairment, SSA use, and weight. This study will provide real-world patient-reported outcomes in CS with XERMELO treatment for at least 6 months.

Study Type

OBSERVATIONAL

Enrollment

223

Conditions

Carcinoid Syndrome

Interventions

XermeloDRUG

This study will include patients with carcinoid syndrome who are initiating treatment with XERMELO.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

RTI-HS

Research Triangle Park, North Carolina, United States

Outcomes

Primary Outcomes

Percentage of Patients Who Are Satisfied With Their Overall Symptom Control

The percentage of CS patients who are satisfied with their overall symptom control, 6 months after initiating treatment with telotristat ethyl (XERMELO). Satisfaction with how Xermelo has controlled diarrhea, flushing, and overall CS symptoms was assessed at the initial 6-month follow-up. The questionnaire allowed participants to choose a response on a 5-level Likert scale ranging from "Very dissatisfied" (level 1) to "Very satisfied" (level 5). For the assessments of satisfaction with control of diarrhea and flushing, "Not applicable" (level 0) was a response option for participants who do not have the particular symptom that is being assessed.

Time frame: Baseline to 6 months

Secondary Outcomes

Percentage of Patients Reporting Satisfaction of CS-related Diarrhea Control

Estimate percentage of patients reporting satisfaction with CS-related diarrhea control from Baseline to 6 months after starting Xermelo. At baseline participants were asked, "Currently, how satisfied are you with how your diarrhea is controlled?" At the 6-month follow-up survey, participants were asked, "Currently, how satisfied are you with how Xermelo has controlled your diarrhea?"

Time frame: Baseline to 6 months

Percentage of Patients Reporting Satisfaction of CS- Related Flushing Control

Estimate percentage of patients reporting satisfaction with CS-related flushing control from Baseline to 6 Months. At baseline, participants who had reported flushing as a symptom were asked, "Currently, how satisfied are you with how your flushing is controlled?" At 6 months, participants who had reported flushing as a symptom at Baseline were asked, "Currently, how satisfied are you with how Xermelo has controlled your flushing?"

Time frame: Baseline to 6 months

Number of Patients Reporting Reduction in Rescue SSA Use

Number of participants reporting a reduction in rescue SSA use at 6 months after initiating treatment with Xermelo.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.