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Fibrate

K-808 Group B for Primary Biliary Cirrhosis

Phase 2

Recruiting

Research Sponsored by Kowa Research Institute, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant is ≥18 years of age at consent

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to weeks 12 and 64

Awards & highlights

Study Summary

This trial will look at how well and how safe two different doses of K-808 (pemafibrate) work in people with Primary Biliary Cholangitis (PBC).

Who is the study for?

This trial is for people with Primary Biliary Cholangitis (PBC) who haven't had enough improvement with standard treatments like Ursodeoxycholic Acid or Obeticholic Acid. Specific eligibility details are not provided, but typically participants must meet certain health standards and may be excluded based on other medical conditions.Check my eligibility

What is being tested?

The study is testing the effectiveness and safety of two different doses of a drug called K-808 (pemafibrate) compared to a placebo. Participants will randomly receive either one of the K-808 doses or a placebo to see if there's an improvement in their PBC symptoms.See study design

What are the potential side effects?

While specific side effects for K-808 (pemafibrate) aren't listed, drugs like it can sometimes cause digestive issues, muscle pain, liver enzyme changes, and fatigue. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to weeks 12 and 64

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to weeks 12 and 64

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to weeks 12 and 64 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent change from baseline in serum alkaline phosphatase (ALP)

Secondary outcome measures

Achievement of normalization of ALP level

Achievement of target levels of ALP and total bilirubin (TB)

Change from baseline in GLOBE risk score

+3 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: K-808 Group BExperimental Treatment1 Intervention

K-808 (Dose B) for 64 Weeks

Group II: K-808 Group AExperimental Treatment1 Intervention

K-808 (Dose A) for 64 Weeks

Group III: Placebo + K-877 (Group B)Placebo Group2 Interventions

Placebo for 12 Weeks followed by K-808 (Dose B) for 52 Weeks

Group IV: Placebo + K-877 (Group A)Placebo Group2 Interventions

Placebo for 12 Weeks followed by K-808 (Dose A) for 52 Weeks

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kowa Research Institute, Inc.Lead Sponsor

44 Previous Clinical Trials

16,375 Total Patients Enrolled

Shona Pendse, MD, MMSCStudy ChairKowa Pharma Development Co.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available slots for patients to participate in this research study?

"As per clinicaltrials.gov, this research is currently seeking participants. The study was initially shared on January 26, 2024 and was most recently revised on January 30, 2024."

Answered by AI

What is the current number of individuals being recruited for participation in this clinical research study?

"Affirmative. Information from clinicaltrials.gov confirms that this particular trial is actively seeking suitable candidates. The initial posting of the trial was on January 26, 2024, with the most recent update dated January 30, 2024. A total of 45 participants are needed across two designated locations for enrollment in this study."

Answered by AI

Has the food and drug administration officially sanctioned K-808 Group A?

"The safety assessment for K-808 Group A received a rating of 2 from our team at Power, as this trial is in Phase 2 where there is existing safety data but no efficacy data available yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Evaluate the Efficacy and Safety of K-808 (Pemafibrate) in Participants With Primary Biliary Cholangitis (PBC) With Inadequate Response to Ursodeoxycholic Acid (UDCA) and/or Obeticholic Acid (OCA) Treatment.

2024. "Study to Evaluate the Efficacy and Safety of K-808 (Pemafibrate) in Participants With Primary Biliary Cholangitis (PBC) With Inadequate Response to Ursodeoxycholic Acid (UDCA) and/or Obeticholic Acid (OCA) Treatment.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06247735.

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