Hepatobiliary DisordersPhase 2NCT06944704
Evaluation of Efficacy, Safety and Molecular Mechanism of Pentoxifylline Supplementation in Patients With Hepatic and Obstructive Jaundice
A Phase 2 study testing Pentoxifylline in people with Hepatobiliary Disorders, run by Tanta University at 1 site in Egypt.
Trial summary
Investigating the efficacy, safety, and molecular mechanism of Pentoxifylline supplementation in improving elevated direct bilirubin level and liver function tests in patients with hepatic and post-hepatic jaundice Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatobiliary Disorders
- What is being tested?
- Pentoxifylline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Apr 2025to 19 Mar 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients age 18-70 years old.
- Patients diagnosed with jaundice and increased level direct bilirubin ≥ 3 mg/dL.
Who cannot join
- Pregnancy.
- Nursing mothers.
- Patients with increased indirect bilirubin level.
- Patients who have Gilbert syndrome or Crigler Najjar syndrome.
- History of intolerance and hypersensitivity to Pentoxifylline or to xanthine derivatives such as caffeine, theophylline.
- Recent hemorrhage.
- Patients who have risk factors potentially complicated by hemorrhage.
- Taking anticoagulants or antiplatelet therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study Evaluating Efficacy, Safety and Molecular Mechanism of Pentoxifylline Supplementation in Patients With Hepatic and Post Hepatic Jaundice
Investigating the efficacy, safety, and molecular mechanism of Pentoxifylline supplementation in improving elevated direct bilirubin level and liver function tests in patients with hepatic and post-hepatic jaundice
- Conditions
- Hepatobiliary Disorders
- Being tested
- Pentoxifylline
- Keywords
- Jaundice, Pentoxifylline, TAC, TNF-α, Bilirubin
- Medical subject headings
- Digestive System Diseases, Jaundice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PentoxifyllineDrug
Patients will receive oral Pentoxifylline 400 mg twice daily in addition to supportive treatment, for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Control arm | No intervention | 20 patients who will receive supportive treatment for jaundice only, for 3 months. |
| PTX arm | Experimental | 20 patients who will receive oral Pentoxifylline 400 mg twice daily in addition to supportive treatment, for 3 months. Receives: Drug: Pentoxifylline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline in (Total and Direct bilirubin)
measurement of(Total and Direct bilirubin) in mg/dL from blood samples will be assessed for all participants.
Measured: The participants will be assessed before initiation of the study (baseline), and at the end of the study up to12 weeks.
The change from baseline in aspartate transaminase (AST), alanine transaminase (ALT), and alkaline phosphatase (ALP)
measurement of aspartate transaminase (AST), alanine transaminase (ALT), and alkaline phosphatase (ALP) all in U/L from blood samples will be assessed for all participants.
Measured: The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.
Secondary outcomes (4)
Adverse events and toxicity
Adverse events and toxicity will be graded using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5
Measured: up to 12 weeks
Change in total antioxidant capacity (TAC) level,
Assessment of total antioxidant capacity (TAC) level by ELISA Kits according to manufacturer's instructions.
Measured: The participants will be assessed before initiation of the study (baseline), and at the end of the study up to 12 weeks.
Change in tumor necrosis factor alpha (TNF-α)
Assessment of tumor necrosis factor alpha (TNF-α) level by ELISA Kits according to manufacturer's instructions.
Measured: The participants will be assessed before initiation of the study (baseline), and at the end of the study up to 12 weeks.
Change in liver-fatty acid binding protein (L-FABP)
Assessment of liver-fatty acid binding protein (L-FABP) level by ELISA Kits according to manufacturer's instructions.
Measured: The participants will be assessed before initiation of the study (baseline), and at the end of the study up to 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start30 Apr 2025
- Primary completion19 Mar 2026
- Study completion19 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatobiliary DisordersStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samah Hussein Mohamed, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06944704
- Sponsor's protocol ID
- TP/RE1/24Ph-1
- Status last verified
- Jul 2026
- First submitted
- 18 Apr 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared to ensure participant privacy and confidentiality, as explicit consent for secondary data sharing was not obtained during the study enrollment.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating Efficacy, Safety and Molecular Mechanism of Pentoxifylline Supplementation in Patients With Hepatic and Post Hepatic Jaundice
- ClinicalTrials.gov ID
- NCT06944704
- Acronym / sponsor ID
- TP/RE1/24Ph-1
- Conditions
- Hepatobiliary Disorders
- Keywords
- Jaundice, Pentoxifylline, TAC, TNF-α, Bilirubin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 19 Mar 2026 (actual)
- Study completion
- 19 Mar 2026 (actual)
- First posted
- 25 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigating the efficacy, safety, and molecular mechanism of Pentoxifylline supplementation in improving elevated direct bilirubin level and liver function tests in patients with hepatic and post-hepatic jaundice
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –20 patients who will receive supportive treatment for jaundice only, for 3 months. |
| PTX arm | Experimental | Drug: Pentoxifylline20 patients who will receive oral Pentoxifylline 400 mg twice daily in addition to supportive treatment, for 3 months. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients age 18-70 years old.
- Patients diagnosed with jaundice and increased level direct bilirubin ≥ 3 mg/dL.
Key exclusion criteria (8 listed)
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PentoxifyllinePatients will receive oral Pentoxifylline 400 mg twice daily in addition to supportive treatment, for 3 months. | Drug | PTX arm |
Primary outcome
The change from baseline in (Total and Direct bilirubin)
Time frame: The participants will be assessed before initiation of the study (baseline), and at the end of the study up to12 weeks.
measurement of(Total and Direct bilirubin) in mg/dL from blood samples will be assessed for all participants.
The change from baseline in aspartate transaminase (AST), alanine transaminase (ALT), and alkaline phosphatase (ALP)
Time frame: The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.
measurement of aspartate transaminase (AST), alanine transaminase (ALT), and alkaline phosphatase (ALP) all in U/L from blood samples will be assessed for all participants.
4 secondary outcomes
Adverse events and toxicity
Time frame: up to 12 weeks
Change in total antioxidant capacity (TAC) level,
Time frame: The participants will be assessed before initiation of the study (baseline), and at the end of the study up to 12 weeks.
Change in tumor necrosis factor alpha (TNF-α)
Time frame: The participants will be assessed before initiation of the study (baseline), and at the end of the study up to 12 weeks.
Change in liver-fatty acid binding protein (L-FABP)
Time frame: The participants will be assessed before initiation of the study (baseline), and at the end of the study up to 12 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared to ensure participant privacy and confidentiality, as explicit consent for secondary data sharing was not obtained during the study enrollment.
Related trials for Hepatobiliary Disorders
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Recruiting
A Trial of Post-Discharge Transitional Care for Patients With Chronic Liver Disease
Liver Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pentoxifylline in people with Hepatobiliary Disorders, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change from baseline in (Total and Direct bilirubin) (time frame: The participants will be assessed before initiation of the study (baseline), and at the end of the study up to12 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.