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Pentoxifylline for Biliary Atresia

Phase 2

Waitlist Available

Led By Ross Shepherd, MD

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

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

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years of age

Awards & highlights

Study Summary

This trial will test whether pentoxifylline can help infants with biliary atresia by reducing liver damage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years of age

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years of age

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years of age for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Number of Participants With Normal Serum Conjugated Bilirubin Levels 12 Weeks After Starting PTX (Pentoxifylline) Therapy

Secondary outcome measures

Alanine Amino Transferase (ALT) Levels at 2 Years of Life

Number of Participants Achieving Zero or Positive Weight Z-scores 12 Weeks After Starting PTX Therapy

Platelet Levels at 2 Years of Life

+2 more

Side effects data

From 2009 Phase 4 trial • 37 Patients • NCT00770328

50%

Nausea/Vomiting

100%

80%

60%

40%

20%

Study treatment Arm

Pentoxifylline

Placebo

Trial Design

1Treatment groups

Experimental Treatment

Group I: PentoxifyllineExperimental Treatment1 Intervention

All newly-diagnosed biliary atresia patients fulfilling the study's inclusion criteria will receive oral pentoxifylline, 20 mg/kg/day divided in three doses for a total of 90 days. The hospital pharmacy will create a 20 mg/ml oral pentoxifylline solution using 400 mg pentoxifylline tablets and established compounding recipes.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pentoxifylline

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor

1,001 Previous Clinical Trials

6,001,935 Total Patients Enrolled

2 Trials studying Biliary Atresia

25 Patients Enrolled for Biliary Atresia

Ross Shepherd, MDPrincipal InvestigatorBaylor College of Medicine

Sanjiv Harpavat, MD PhD5.01 ReviewsPrincipal Investigator - Baylor College of Medicine

Baylor College of Medicine

Frequently Asked Questions

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

In what medical scenarios is Pentoxifylline typically prescribed?

"Pentoxifylline has been demonstrated to be effective at treating a range of conditions, including alcoholic liver diseases, venous leg ulcer (vlu), and intermittent claudication."

Answered by AI

What adverse effects may arise from using Pentoxifylline?

"There is evidence of Pentoxifylline's safety, thus it was allocated a 2 rating on our scale. However, no clinical data exists yet to support its efficacy."

Answered by AI

Are any participants currently being enrolled in this experiment?

"Clinicaltrials.gov denotes that, as of 2/1/2023, this medical study is actively recruiting volunteers. The trial was initially posted on 1/1/2013 and has experienced modifications since its inception."

Answered by AI

Have any other investigations explored the potential of Pentoxifylline?

"Currently, there are 10 ongoing clinical trials concerning Pentoxifylline with 3 in their third phase. Participants can be found at 27 various sites, many of them located in Houston, Texas."

Answered by AI

How many participants are being enrolled in this research?

"Affirmative, the information hosted on clinicaltrials.gov exhibits that this medical trial is actively searching for participants. This research was first shared online on January 1st 2013 and has since been updated to its current iteration as of February 1st 2023. The study requires 60 patients from a single site."

Answered by AI

Recent research and studies

Controlled Clinical TrialsJournal

Optimal Two-stage Designs for Phase II Clinical Trials

Simon, Richard. 1989. “Optimal Two-stage Designs for Phase II Clinical Trials”. Controlled Clinical Trials. Elsevier BV. doi:10.1016/0197-2456(89)90015-9.

HepatologyJournal

Screening and Outcomes in Biliary Atresia: Summary of a National Institutes of Health Workshop

Sokol, Ronald J., Ross W. Shepherd, Riccardo Superina, Jorge A. Bezerra, Patricia Robuck, and Jay H. Hoofnagle. 2007. “Screening and Outcomes in Biliary Atresia: Summary of a National Institutes of Health Workshop”. Hepatology. Wiley. doi:10.1002/hep.21790.

clinicaltrials.govStudy

Pentoxifylline Therapy in Biliary Atresia

Sanjiv Harpavat 2013. "Pentoxifylline Therapy in Biliary Atresia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01774487.