Trial · NCT01774487
Pentoxifylline Therapy in Biliary Atresia
NCT01774487, Phase 2, Terminated, Baylor College of Medicine; results first posted 2023-10-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pentoxifylline Therapy in Biliary Atresia. Trials, record NCT01774487. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01774487
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pentoxifylline Therapy in Biliary Atresia
- NCT number
- NCT01774487
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- Baylor College of Medicine
- Conditions
- Biliary Atresia
- Interventions
- Pentoxifylline
- First posted
- 2013-01-24
- Last updated
- 2024-01-11
- Results first posted
- 2023-10-12
- Limitations and caveats
- Because of early termination, this study did not reach the target number of participants needed to achieve target power and statistically reliable results.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Normal Serum Conjugated Bilirubin Levels 12 Weeks After Starting PTX (Pentoxifylline) Therapy | 12 weeks after starting therapy | The investigators will track the serum conjugated bilirubin (CB) levels over the course of therapy in patients receiving 90 days of PTX (this laboratory test is drawn as part of routine care). Normal CB is 0.0-0.3 mg/dL, with a higher number of patients meeting this indicating a better outcome. |
| Secondary | Number of Participants Achieving Zero or Positive Weight Z-scores 12 Weeks After Starting PTX Therapy | 12 weeks after starting therapy | The investigators will track the weight of patients over the course of therapy in patients receiving 90 days of PTX (this is recorded as part of routine clinical care). The weight will then be compared to standards to calculate a z-score. Normal weight Z-score is greater than or equal to 0, with a higher number of patients meeting this indicating a better outcome. |
| Secondary | Alanine Amino Transferase (ALT) Levels at 2 Years of Life | 2 years of age | The investigators will record the ALT levels at age two years, in patients who had previously been treated with PTX therapy and still have their native liver. Range of normal values: 14-45 U/L, with a higher level indicating a worse outcome. |
| Secondary | Spleen Size at 2 Years of Age | 2 years of age | The investigators will measure spleen size by ultrasound at 2 years of age, in patients who had received PTX therapy earlier and still have their native liver. "Normal" spleen size range (10th-90th percentile) at this age is 6.4-8.6 cm, with a value exceeding this range indicating a worse outcome. |
| Secondary | Time to Liver Transplant | Baseline and up to two years after therapy finishes | The investigators will track time to liver transplant. The shorter time to liver transplant indicates a worse outcome. |
| Secondary | Platelet Levels at 2 Years of Life | 2 years of age | The investigators will record platelet levels at age two years, in patients who had previously been treated with PTX therapy and still have their native liver. Scale 189-403\*10\^3 Platelets/μL, with a lower level indicating a worse outcome. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Normal Serum Conjugated Bilirubin Levels 12 Weeks After Starting PTX (Pentoxifylline) Therapy | 12 weeks after starting therapy | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Achieving Zero or Positive Weight Z-scores 12 Weeks After Starting PTX Therapy | 12 weeks after starting therapy | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Alanine Amino Transferase (ALT) Levels at 2 Years of Life | 2 years of age | No patient in Group 2 survived with their native liver to 2 years of age. | U/L | MEAN |
| SECONDARY | Spleen Size at 2 Years of Age | 2 years of age | No patient in Group 2 survived with their native liver to 2 years of age. | cm | MEAN |
| SECONDARY | Time to Liver Transplant | Baseline and up to two years after therapy finishes | days | MEAN | |
| SECONDARY | Platelet Levels at 2 Years of Life | 2 years of age | No patient in Group 2 survived with their native liver to 2 years of age. | 10^3 Platelets/μL | MEAN |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Normal Serum Conjugated Bilirubin Levels 12 Weeks After Starting PTX (Pentoxifylline) Therapy | Pentoxifylline - Group 1 | 6 | Participants | ||
| Number of Participants With Normal Serum Conjugated Bilirubin Levels 12 Weeks After Starting PTX (Pentoxifylline) Therapy | Pentoxifylline - Group 2 | 0 | Participants | ||
| Number of Participants Achieving Zero or Positive Weight Z-scores 12 Weeks After Starting PTX Therapy | Pentoxifylline - Group 1 | 0 | Participants | ||
| Number of Participants Achieving Zero or Positive Weight Z-scores 12 Weeks After Starting PTX Therapy | Group 2 | 0 | Participants | ||
| Alanine Amino Transferase (ALT) Levels at 2 Years of Life | Pentoxifylline - Group 1 | 160 | Standard Deviation 122 | U/L | |
| Spleen Size at 2 Years of Age | Pentoxifylline - Group 1 | 10.0 | Standard Deviation 1.8 | cm | |
| Time to Liver Transplant | Pentoxifylline - Group 1 | 317 | Standard Deviation 95 | days | |
| Time to Liver Transplant | Pentoxifylline - Group 2 | 273 | Standard Deviation NA | days | |
| Platelet Levels at 2 Years of Life | Pentoxifylline - Group 1 | 208 | Standard Deviation 102 | 10^3 Platelets/μL |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pentoxifylline - Group 1 (Treatment Starts 3-5 Days After Kasai Portoenterostomy) | 12 | |
| Overall Study | STARTED | Pentoxifylline - Group 2 (Patient Diagnosed Too Late for Kasai Portoenterostomy) | 5 | |
| Overall Study | COMPLETED | Pentoxifylline - Group 1 (Treatment Starts 3-5 Days After Kasai Portoenterostomy) | 8 | |
| Overall Study | COMPLETED | Pentoxifylline - Group 2 (Patient Diagnosed Too Late for Kasai Portoenterostomy) | 1 | |
| Overall Study | NOT COMPLETED | Pentoxifylline - Group 1 (Treatment Starts 3-5 Days After Kasai Portoenterostomy) | 4 | |
| Overall Study | NOT COMPLETED | Pentoxifylline - Group 2 (Patient Diagnosed Too Late for Kasai Portoenterostomy) | 4 |
Source ClinicalTrials.gov
Adverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ALT >2.5X baseline | Hepatobiliary disorders | Pentoxifylline - Group 1 (Treatment Starts 3-5 Days After Kasai Portoenterostomy) | 1 | 8 | 1 |
| other | ALT >2.5X baseline | Hepatobiliary disorders | Pentoxifylline - Group 2 (Patient Diagnosed Too Late for Kasai Portoenterostomy) | 0 | 1 | 0 |
| other | Bc >2.5X baseline | Hepatobiliary disorders | Pentoxifylline - Group 1 (Treatment Starts 3-5 Days After Kasai Portoenterostomy) | 0 | 8 | 0 |
| other | Bc >2.5X baseline | Hepatobiliary disorders | Pentoxifylline - Group 2 (Patient Diagnosed Too Late for Kasai Portoenterostomy) | 0 | 1 | 0 |
| other | Platelets <150,000/ul | Blood and lymphatic system disorders | Pentoxifylline - Group 1 (Treatment Starts 3-5 Days After Kasai Portoenterostomy) | 3 | 8 | 3 |
| other | Platelets <150,000/ul | Blood and lymphatic system disorders | Pentoxifylline - Group 2 (Patient Diagnosed Too Late for Kasai Portoenterostomy) | 1 | 1 | 1 |
| other | Vomiting | Gastrointestinal disorders | Pentoxifylline - Group 1 (Treatment Starts 3-5 Days After Kasai Portoenterostomy) | 2 | 8 | 2 |
| other | Vomiting | Gastrointestinal disorders | Pentoxifylline - Group 2 (Patient Diagnosed Too Late for Kasai Portoenterostomy) | 1 | 1 | 5 |
| other | Stopped medication before 12 week period | Product Issues | Pentoxifylline - Group 1 (Treatment Starts 3-5 Days After Kasai Portoenterostomy) | 2 | 8 | 2 |
| other | Stopped medication before 12 week period | Product Issues | Pentoxifylline - Group 2 (Patient Diagnosed Too Late for Kasai Portoenterostomy) | 0 | 1 | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pentoxifylline - Group 1 (Treatment Starts 3-5 Days After Kasai Portoenterostomy) | 0 | 8 |
| Total, all-cause mortality | Pentoxifylline - Group 2 (Patient Diagnosed Too Late for Kasai Portoenterostomy) | 0 | 1 |
| Total, other adverse events | Pentoxifylline - Group 1 (Treatment Starts 3-5 Days After Kasai Portoenterostomy) | 4 | 8 |
| Total, other adverse events | Pentoxifylline - Group 2 (Patient Diagnosed Too Late for Kasai Portoenterostomy) | 1 | 1 |
| Total, serious adverse events | Pentoxifylline - Group 1 (Treatment Starts 3-5 Days After Kasai Portoenterostomy) | 6 | 8 |
| Total, serious adverse events | Pentoxifylline - Group 2 (Patient Diagnosed Too Late for Kasai Portoenterostomy) | 1 | 1 |
Source ClinicalTrials.gov
Papers15
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Pentoxifylline - Group 1 vs Group 2: Number of Participants Achieving Zero or Positive Weight Z-scores 12 Weeks After Starting PTX Therapy | Trial comparisons |
| Pentoxifylline - Group 1 vs Pentoxifylline - Group 2: Number of Participants With Normal Serum Conjugated Bilirubin Levels 12 Weeks After Starting PTX (Pentoxifylline) Therapy | Trial comparisons |
| Pentoxifylline - Group 1 (Treatment Starts 3-5 Days After Kasai Portoenterostomy) vs Pentoxifylline - Group 2 (Patient Diagnosed Too Late for Kasai Portoenterostomy): deaths from any cause | Trial comparisons |
| Pentoxifylline - Group 1 (Treatment Starts 3-5 Days After Kasai Portoenterostomy) vs Pentoxifylline - Group 2 (Patient Diagnosed Too Late for Kasai Portoenterostomy): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01774487
GET https://conductscience.org/api/trials/v1/NCT01774487/registered