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Crofelemer

Phase 3

HIV Associated Diarrhea | Small molecule | Infectious Disease |Bausch Health Companies Inc.|Last Updated: Sep 3, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment374

FDA Designations

No designations recorded

Clinical trial landscape

Crofelemer · 4 trials · 7 indications

Phase 3 2Phase 2 2
NCT01374490Safety and Tolerability of Crofelemer for HIV-Associated DiarrheaHIV Enteropathy
COMPLETED250 Analytics
NCT00547898Safety and Effectiveness of 3 Doses of Crofelemer Compared to Placebo in the Treatment of HIV Associated DiarrheaHIV Associated Diarrhea
COMPLETED374 Analytics
PHASE3COMPLETED
Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea
HIV Enteropathy
NCT01374490250
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PHASE3COMPLETED
Safety and Effectiveness of 3 Doses of Crofelemer Compared to Placebo in the Treatment of HIV Associated Diarrhea
HIV Associated Diarrhea
NCT00547898374
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Study Endpoints

Primary Endpoints

Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).
48 weeks
Primary Efficacy Outcome is Count of Participants With Two or Less Watery Bowel Movements Per Week During at Least Two Weeks of the Treatment Phase of the Optimal Dose of Crofelemer Compared to Placebo
31 days
To assess the safety of TRN-002 when administered twice daily for 12 consecutive weeks.
March 2008
To assess the efficacy of TRN-002 when administered twice daily for 12 consecutive weeks.
March 2008

Secondary Endpoints

To assess the efficacy of TRN-002 when administered twice daily for 12 consecutive weeks.
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CrofelemerEXPERIMENTAL -
PlaceboEXPERIMENTAL -
Crofelemer 125 mgEXPERIMENTAL -
Crofelemer 250 mgEXPERIMENTAL -
Crofelemer 500 mgEXPERIMENTAL -
125 mg crofelemerEXPERIMENTAL -
250 mg crofelemerEXPERIMENTAL -
500 mg crofelemerEXPERIMENTAL -

Interventions

NameTypeDescription
CrofelemerDRUGCrofelemer will be administered orally as 1 tablet(125 mg)BID for a total daily dose of 250mg crofelemer.
Crofelemer 125 mgDRUGCrofelemer 125 mg
Crofelemer 250 mgDRUGCrofelemer 250 mg
Crofelemer 500 mgDRUGCrofelemer 500 mg
PlaceboDRUGPlacebo
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: * Male or female ≥ 18 years old * History of HIV-1 infection * On an antiretroviral therapeutic regimen for treatment of HIV-1 disease and associated conditions (including prophylactic antibiotics for Pneumocystis jirovecii or infection) for at least 4 weeks prior to screening *...

Countries:United StatesPuerto Rico
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Frequently asked questions about Crofelemer

What is Crofelemer used for?

Crofelemer is an investigational small molecule being studied for HIV enteropathy, HIV associated diarrhea, and irritable bowel syndrome. It is in Phase 3 clinical development for these indications. The drug is being developed by Bausch Health Companies Inc. (BHC).

How does Crofelemer work?

Crofelemer is a small molecule that targets chloride channels in the gastrointestinal tract. By inhibiting these channels, it reduces fluid secretion and diarrhea. This mechanism is being studied in conditions like HIV associated diarrhea and irritable bowel syndrome.

Who makes Crofelemer?

Crofelemer is being developed by Bausch Health Companies Inc., which trades under the ticker BHC. The company is conducting clinical trials to evaluate the drug for HIV enteropathy, HIV associated diarrhea, and irritable bowel syndrome.

What phase is Crofelemer in?

Crofelemer is in Phase 3 clinical development. It is not FDA approved and remains investigational. The drug is being studied for HIV enteropathy, HIV associated diarrhea, and irritable bowel syndrome, with completed Phase 3 trials in HIV associated diarrhea.

What clinical trials is Crofelemer in?

Crofelemer has completed four clinical trials, including NCT00547898 and NCT01374490 for HIV associated diarrhea, and NCT00101725 and NCT00461526 for irritable bowel syndrome. These trials were Phase 2 and Phase 3, with a total enrollment of 485 participants.

Is Crofelemer the same as any other drug?

Crofelemer is also known by the brand name Mytesi. It is being developed by Bausch Health Companies Inc. for HIV associated diarrhea and irritable bowel syndrome. The drug is in Phase 3 clinical development.