Biliary AtresiaPhase 2BA_GCSF2bNCT04373941
Part II: Granulocyte-Colony Stimulating Factor Adjunct Therapy for Biliary Atresia
A Phase 2 study testing Filgrastim in people with Biliary Atresia, run by Holterman, Ai-Xuan, M.D. at 4 sites in 3 countries.
Trial summary
The Investigators propose to test the hypothesis that GCSF enhances the clinical outcome of biliary atresia in a multi-institutional Phase 2 trial to prospectively evaluate the safety and efficacy of GCSF in each of the 2 groups of newly diagnosed BA patients: KBA (i.e., Kasai-operated) or NoK (i.e., patients who did… Read more about this study
- Who is it for?
- Ages 14 to 180 days
- Conditions the study is for
- Biliary Atresia
- What is being tested?
- Filgrastim
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 1 Sep 2023to 31 Oct 2025
- 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 14 to 180 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- preliminary work up for cholestasis suspected or inconclusive diagnosis of BA.
- Serum Direct bilirubin > 2 mg/dl,GGT> 100 U/L
- Male or female infants with a gestational age> 36 weeks
- Admission weight > 2 kg
- Age > 14 days - 180 days at diagnosis
- For Kasai operated subjects, Type 3 or 4 anatomy of BA
- For Kasai operated subjects, cholangiogram (if performed) diagnostic of BA
- Liver biopsy supporting BA diagnosis
Who cannot join
- Patients having access to liver transplantation for immediate liver failure
- Prior Kasai patients
- Major cardiac, renal, central nervous system (CNS) malformations
- Intracranial hemorrhage
- History of recent total parenteral nutrition (TPN) use within the last 2 weeks
- Gl tract obstruction
Show all 13Show fewer
- For Kasai-operated subjects: Type 1 or 2 biliary atresia anatomy
- Current systemic infection
- WBC > 20,000 cells/uL
- Platelet count < 20,000 cells/uL or >1 million cells/uL
- Concurrent respiratory, metabolic, neurological, cardiovascular, metabolic, and renal illness
- Elevated serum creatinine > 1 mg/dL
- Purpura fulminans or unexplained vascular thrombosis
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Vietnam2 sites, 2 recruiting
- Recruiting
Nation Children's Hospital
Hanoi, Dong Da District
Pham Anh Hoa Nguyen, MD, +84 462738842, drhoanph@yahoo.com
Thuy Trinh, MD, +84 984078256, bsthuya7@gmail.com
- Enrolling by invitation
Children Hospital 1
Ho Chi Minh City
United States1 site, 1 recruiting
- Not yet recruiting
Oregon Health & Science University (OHSU)
Portland, Oregon, 97239
Marilyn Butler, MD, butlerm@ohsu.edu
Andrew Mason, 6232413831, masoned@ohsu.edu
Pakistan1 site, 1 recruiting
- Not yet recruiting
Aga Khan University
Karachi
Saqib Qazi, MD, +923018233059, saqib.qazi@aku.edu
About this study
Official title: Granulocyte-Colony Stimulating Factor Adjunct Therapy for Biliary Atresia: Part II of a Prospective, Randomized Controlled, Multi-Institutional Trial
The Investigators propose to test the hypothesis that GCSF enhances the clinical outcome of biliary atresia in a multi-institutional Phase 2 trial to prospectively evaluate the safety and efficacy of GCSF in each of the 2 groups of newly diagnosed BA patients: KBA (i.e., Kasai-operated) or NoK (i.e., patients who did not undergo Kasai surgery). Subjects who participate in the trial will be followed for 2 years.
Read the detailed description
This is a prospective, randomized, multi-institutional trial in KBA and NoK subjects to be conducted under a Food and Drug Administration approved Investigational New Drug application.
The KBA group is composed of just operated Kasai patients with intraoperative liver biopsy-confirmed BA. Their clinical characteristics have been described in the previously completed Phase 1 study under CR00005169 (ie. inclusion and exclusion criteria as described below)
The NoK group will be composed of newly diagnosed BA patients, including the following:
- surgical patients in whom the Kasai was not performed for intraoperative technical reasons or due to advanced liver disease, who also have no option for rescue liver transplantation.
- Unoperated patients whose family refuses surgery or who are not operative candidates
Having met the same inclusion and exclusion criteria as the Kasai KBS group,
- eligible KBA subjects will be randomized to GCSF vs. no-GCSF at the 10 ug/kg/d dose to be given subcutaneously for 3 consecutive daily doses on the third day following the Kasai procedure.
- eligible NoK subjects will be randomized to GCSF vs. no-GCSF at the 10 ug/kg/d dose to be given subcutaneously for 3 consecutive daily doses on the third day following diagnostic liver biopsy.
- Conditions
- Biliary Atresia
- Being tested
- Filgrastim
- Medical subject headings
- Biliary Atresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FilgrastimDrug
Also called Neupogen, granulocyte colony stimulating factor
G-CSF is a glycoprotein produced by monocytes, fibroblasts, and endothelial cells. Filgrastim is a human granulocyte colony stimulating factor (G-CSF) produced by recombinant DNA technology with NEUPOGEN® as the Amgen Inc. trademark for filgrastim. G-CSF regulates the production, proliferation and differentiation of neutrophils and hematopoietic stem cell precursors within the bone marrow leading to dose-dependent increase in circulating neutrophils and hematopoietic stem cells in the blood. It is indicated to reduce the incidence of infection in patients with severe neutropenia, for neutrophil recovery in neutropenic patients with bone marrow depletion, to mobilize hematopoietic progenitor stem cell for collection by leukapheresis in hematopoietic stem cell transplantation.
| Study group | Role | What they receive |
|---|---|---|
| Kasai GCSF | Experimental | The Kasai GCSF group will receive the standard of care PLUS 3 consecutive daily doses of 10 ug/kg of GCSF to be administered subcutaneously by day 3 post Kasai surgery Receives: Drug: Filgrastim |
| Kasai no GCSF | No intervention | The no GCSF group will not receive GCSF and receives the standard of care |
| No Kasai GCSF | Experimental | The No Kasai GCSF group will receive the standard of care PLUS 3 consecutive daily doses of 10 ug/kg of GCSF to be administered subcutaneously once the diagnosis of BA is established Receives: Drug: Filgrastim |
| No Kasai No GCSF | No intervention | The No Kasai No GCSF group will receive the standard of care and will not receive GCSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
GCSF Response on Bile flow (KBA)
For KBA subjects: Bile flow as measured by the percentage of subjects with total bilirubin< 2 mg/dL at 3 months post-Kasai.
Measured: 3 months
GCSF Response on transplant-free survival (NoK)
For NoK subjects: Changes at 6, 12, 18 and 24 months-transplant free survival
Measured: 24 months
Secondary outcomes (4)
GCSF response on liver function and outcome (KBA)
KBA subjects: Pediatric end-stage liver disease (PELD) score at 6, 12, 18, and 24 months after GCSF treatment.
Measured: 24 months
GCSF response on liver function and outcome (KBA)
KBA subjects: Percentage of patients with transplant-free survival at 6, 12, 18 and 24 months
Measured: 24 months
GCSF response on liver function and outcome (KBA)
KBA subjects: Percentage of patients with cholangitis-free transplant-free survival at 6, 12, 18 and 24 months
Measured: 24 months
GCSF response on liver function (NoK)
NoK subjects: Changes in Pediatric end-stage liver disease (PELD) score at 6, 12, 18, and 24 months after GCSF treatment.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start1 Sep 2023 (estimated)
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Biliary AtresiaStudies of the same condition, open and under way.
- 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
- Model description
- GCSF or No-GCSF
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Holterman, Ai-Xuan, M.D.
- Collaborators
- T Rose Clinical, Inc., Big Leap Research, Prometheus USA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04373941
- Sponsor's protocol ID
- HoltermanA
- Acronym
- BA_GCSF2b
- Status last verified
- Sep 2023
- First submitted
- 13 Aug 2019
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bezerra JA, Wells RG, Mack CL, Karpen SJ, Hoofnagle JH, Doo E, Sokol RJ. Biliary Atresia: Clinical and Research Challenges for the Twenty-First Century. Hepatology. 2018 Sep;68(3):1163-1173. doi: 10.1002/hep.29905.
PubMed 29604222Chaudhuri J, Mitra S, Mukhopadhyay D, Chakraborty S, Chatterjee S. Granulocyte Colony-stimulating Factor for Preterms with Sepsis and Neutropenia: A Randomized Controlled Trial. J Clin Neonatol. 2012 Oct;1(4):202-6. doi: 10.4103/2249-4847.105993.
PubMed 24027727Shneider BL, Magee JC, Karpen SJ, Rand EB, Narkewicz MR, Bass LM, Schwarz K, Whitington PF, Bezerra JA, Kerkar N, Haber B, Rosenthal P, Turmelle YP, Molleston JP, Murray KF, Ng VL, Wang KS, Romero R, Squires RH, Arnon R, Sherker AH, Moore J, Ye W, Sokol RJ; Childhood Liver Disease Research Network (ChiLDReN). Total Serum Bilirubin within 3 Months of Hepatoportoenterostomy Predicts Short-Term Outcomes in Biliary Atresia. J Pediatr. 2016 Mar;170:211-7.e1-2. doi: 10.1016/j.jpeds.2015.11.058. Epub 2015 Dec 24.
PubMed 26725209Kedarisetty CK, Anand L, Bhardwaj A, Bhadoria AS, Kumar G, Vyas AK, David P, Trehanpati N, Rastogi A, Bihari C, Maiwall R, Garg HK, Vashishtha C, Kumar M, Bhatia V, Sarin SK. Combination of granulocyte colony-stimulating factor and erythropoietin improves outcomes of patients with decompensated cirrhosis. Gastroenterology. 2015 Jun;148(7):1362-70.e7. doi: 10.1053/j.gastro.2015.02.054. Epub 2015 Mar 4.
PubMed 25749502Fanna M, Masson G, Capito C, Girard M, Guerin F, Hermeziu B, Lachaux A, Roquelaure B, Gottrand F, Broue P, Dabadie A, Lamireau T, Jacquemin E, Chardot C. Management of Biliary Atresia in France 1986 to 2015: Long-term Results. J Pediatr Gastroenterol Nutr. 2019 Oct;69(4):416-424. doi: 10.1097/MPG.0000000000002446.
PubMed 31335841Verma N, Kaur A, Sharma R, Bhalla A, Sharma N, De A, Singh V. Outcomes after multiple courses of granulocyte colony-stimulating factor and growth hormone in decompensated cirrhosis: A randomized trial. Hepatology. 2018 Oct;68(4):1559-1573. doi: 10.1002/hep.29763. Epub 2018 Jul 25.
PubMed 29278428Spahr L, Lambert JF, Rubbia-Brandt L, Chalandon Y, Frossard JL, Giostra E, Hadengue A. Granulocyte-colony stimulating factor induces proliferation of hepatic progenitors in alcoholic steatohepatitis: a randomized trial. Hepatology. 2008 Jul;48(1):221-9. doi: 10.1002/hep.22317.
PubMed 18537187Korbling M, Freireich EJ. Twenty-five years of peripheral blood stem cell transplantation. Blood. 2011 Jun 16;117(24):6411-6. doi: 10.1182/blood-2010-12-322214. Epub 2011 Apr 1.
PubMed 21460243Nguyen HPA, Ren J, Butler M, Li H, Qazi S, Sadiq K, Dao HT, Holterman A. Study protocol of Phase 2 open-label multicenter randomized controlled trial for granulocyte-colony stimulating factor (GCSF) in post-Kasai Type 3 biliary atresia. Pediatr Surg Int. 2022 Jul;38(7):1019-1030. doi: 10.1007/s00383-022-05115-0. Epub 2022 Apr 7.
PubMed 35391541
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Granulocyte-Colony Stimulating Factor Adjunct Therapy for Biliary Atresia: Part II of a Prospective, Randomized Controlled, Multi-Institutional Trial
- ClinicalTrials.gov ID
- NCT04373941
- Acronym / sponsor ID
- BA_GCSF2b / HoltermanA
- Conditions
- Biliary Atresia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Holterman, Ai-Xuan, M.D.
- Collaborators
- T Rose Clinical, Inc., Big Leap Research, Prometheus USA
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 5 May 2020 (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.
The Investigators propose to test the hypothesis that GCSF enhances the clinical outcome of biliary atresia in a multi-institutional Phase 2 trial to prospectively evaluate the safety and efficacy of GCSF in each of the 2 groups of newly diagnosed BA patients: KBA (i.e., Kasai-operated) or NoK (i.e., patients who did not undergo Kasai surgery). Subjects who participate in the trial will be followed for 2 years.
Detailed description
This is a prospective, randomized, multi-institutional trial in KBA and NoK subjects to be conducted under a Food and Drug Administration approved Investigational New Drug application.
The KBA group is composed of just operated Kasai patients with intraoperative liver biopsy-confirmed BA. Their clinical characteristics have been described in the previously completed Phase 1 study under CR00005169 (ie. inclusion and exclusion criteria as described below)
The NoK group will be composed of newly diagnosed BA patients, including the following:
- surgical patients in whom the Kasai was not performed for intraoperative technical reasons or due to advanced liver disease, who also have no option for rescue liver transplantation.
- Unoperated patients whose family refuses surgery or who are not operative candidates
Having met the same inclusion and exclusion criteria as the Kasai KBS group,
- eligible KBA subjects will be randomized to GCSF vs. no-GCSF at the 10 ug/kg/d dose to be given subcutaneously for 3 consecutive daily doses on the third day following the Kasai procedure.
- eligible NoK subjects will be randomized to GCSF vs. no-GCSF at the 10 ug/kg/d dose to be given subcutaneously for 3 consecutive daily doses on the third day following diagnostic liver biopsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- GCSF or No-GCSF
| Arm | Type | Receives |
|---|---|---|
| Kasai GCSF | Experimental | Drug: FilgrastimThe Kasai GCSF group will receive the standard of care PLUS 3 consecutive daily doses of 10 ug/kg of GCSF to be administered subcutaneously by day 3 post Kasai surgery |
| Kasai no GCSF | No intervention | –The no GCSF group will not receive GCSF and receives the standard of care |
| No Kasai GCSF | Experimental | Drug: FilgrastimThe No Kasai GCSF group will receive the standard of care PLUS 3 consecutive daily doses of 10 ug/kg of GCSF to be administered subcutaneously once the diagnosis of BA is established |
| No Kasai No GCSF | No intervention | –The No Kasai No GCSF group will receive the standard of care and will not receive GCSF |
Who may qualify
- Ages
- 14 to 180 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- preliminary work up for cholestasis suspected or inconclusive diagnosis of BA.
- Serum Direct bilirubin > 2 mg/dl,GGT> 100 U/L
- Male or female infants with a gestational age> 36 weeks
- Admission weight > 2 kg
- Age > 14 days - 180 days at diagnosis
Key exclusion criteria (13 listed)
- Patients having access to liver transplantation for immediate liver failure
- Prior Kasai patients
- Major cardiac, renal, central nervous system (CNS) malformations
- Intracranial hemorrhage
- History of recent total parenteral nutrition (TPN) use within the last 2 weeks
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 |
|---|---|---|
| FilgrastimAlso: Neupogen, granulocyte colony stimulating factorG-CSF is a glycoprotein produced by monocytes, fibroblasts, and endothelial cells. Filgrastim is a human granulocyte colony stimulating factor (G-CSF) produced by recombinant DNA technology with NEUPOGEN® as the Amgen Inc. trademark for filgrastim. G-CSF regulates the production, proliferation and differentiation of neutrophils and hematopoietic stem cell precursors within the bone marrow leading to dose-dependent increase in circulating neutrophils and hematopoietic stem cells in the blood. It is indicated to reduce the incidence of infection in patients with severe neutropenia, for neutrophil recovery in neutropenic patients with bone marrow depletion, to mobilize hematopoietic progenitor stem cell for collection by leukapheresis in hematopoietic stem cell transplantation. | Drug | Kasai GCSF, No Kasai GCSF |
Primary outcome
GCSF Response on Bile flow (KBA)
Time frame: 3 months
For KBA subjects: Bile flow as measured by the percentage of subjects with total bilirubin< 2 mg/dL at 3 months post-Kasai.
GCSF Response on transplant-free survival (NoK)
Time frame: 24 months
For NoK subjects: Changes at 6, 12, 18 and 24 months-transplant free survival
4 secondary outcomes
GCSF response on liver function and outcome (KBA)
Time frame: 24 months
GCSF response on liver function and outcome (KBA)
Time frame: 24 months
GCSF response on liver function and outcome (KBA)
Time frame: 24 months
GCSF response on liver function (NoK)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Background: PubMed 29604222Bezerra JA, Wells RG, Mack CL, Karpen SJ, Hoofnagle JH, Doo E, Sokol RJ. Biliary Atresia: Clinical and Research Challenges for the Twenty-First Century. Hepatology. 2018 Sep;68(3):1163-1173. doi: 10.1002/hep.29905.
- Background: PubMed 24027727Chaudhuri J, Mitra S, Mukhopadhyay D, Chakraborty S, Chatterjee S. Granulocyte Colony-stimulating Factor for Preterms with Sepsis and Neutropenia: A Randomized Controlled Trial. J Clin Neonatol. 2012 Oct;1(4):202-6. doi: 10.4103/2249-4847.105993.
- Background: PubMed 26725209Shneider BL, Magee JC, Karpen SJ, Rand EB, Narkewicz MR, Bass LM, Schwarz K, Whitington PF, Bezerra JA, Kerkar N, Haber B, Rosenthal P, Turmelle YP, Molleston JP, Murray KF, Ng VL, Wang KS, Romero R, Squires RH, Arnon R, Sherker AH, Moore J, Ye W, Sokol RJ; Childhood Liver Disease Research Network (ChiLDReN). Total Serum Bilirubin within 3 Months of Hepatoportoenterostomy Predicts Short-Term Outcomes in Biliary Atresia. J Pediatr. 2016 Mar;170:211-7.e1-2. doi: 10.1016/j.jpeds.2015.11.058. Epub 2015 Dec 24.
- Background: PubMed 25749502Kedarisetty CK, Anand L, Bhardwaj A, Bhadoria AS, Kumar G, Vyas AK, David P, Trehanpati N, Rastogi A, Bihari C, Maiwall R, Garg HK, Vashishtha C, Kumar M, Bhatia V, Sarin SK. Combination of granulocyte colony-stimulating factor and erythropoietin improves outcomes of patients with decompensated cirrhosis. Gastroenterology. 2015 Jun;148(7):1362-70.e7. doi: 10.1053/j.gastro.2015.02.054. Epub 2015 Mar 4.
- Background: PubMed 31335841Fanna M, Masson G, Capito C, Girard M, Guerin F, Hermeziu B, Lachaux A, Roquelaure B, Gottrand F, Broue P, Dabadie A, Lamireau T, Jacquemin E, Chardot C. Management of Biliary Atresia in France 1986 to 2015: Long-term Results. J Pediatr Gastroenterol Nutr. 2019 Oct;69(4):416-424. doi: 10.1097/MPG.0000000000002446.
- Background: PubMed 29278428Verma N, Kaur A, Sharma R, Bhalla A, Sharma N, De A, Singh V. Outcomes after multiple courses of granulocyte colony-stimulating factor and growth hormone in decompensated cirrhosis: A randomized trial. Hepatology. 2018 Oct;68(4):1559-1573. doi: 10.1002/hep.29763. Epub 2018 Jul 25.
- Background: PubMed 18537187Spahr L, Lambert JF, Rubbia-Brandt L, Chalandon Y, Frossard JL, Giostra E, Hadengue A. Granulocyte-colony stimulating factor induces proliferation of hepatic progenitors in alcoholic steatohepatitis: a randomized trial. Hepatology. 2008 Jul;48(1):221-9. doi: 10.1002/hep.22317.
- Background: PubMed 21460243Korbling M, Freireich EJ. Twenty-five years of peripheral blood stem cell transplantation. Blood. 2011 Jun 16;117(24):6411-6. doi: 10.1182/blood-2010-12-322214. Epub 2011 Apr 1.
- Derived from this study: PubMed 35391541Nguyen HPA, Ren J, Butler M, Li H, Qazi S, Sadiq K, Dao HT, Holterman A. Study protocol of Phase 2 open-label multicenter randomized controlled trial for granulocyte-colony stimulating factor (GCSF) in post-Kasai Type 3 biliary atresia. Pediatr Surg Int. 2022 Jul;38(7):1019-1030. doi: 10.1007/s00383-022-05115-0. Epub 2022 Apr 7.
- Individual participant dataSharing planned: No
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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.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Filgrastim in people with Biliary Atresia, run by Holterman, Ai-Xuan, M.D. at 4 sites in 3 countries.
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 8 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Vietnam, United States, Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact AiXuan Holterman, MD (8473340230, Aithanh@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GCSF Response on Bile flow (KBA) (time frame: 3 months). 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?
On the ClinicalTrials.gov record for NCT04373941, which also lists 9 linked publications.
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 8 Sep 2023.