Phase 2
N=30
Safety Study of Intravenous Immunoglobulin (IVIG) Post-Portoenterostomy in Infants With Biliary Atresia
Biliary Atresia
Bottom Line
View on ClinicalTrials.gov: NCT01854827 ↗Enrolled (actual)
30
Serious AEs
89.7%
Results posted
May 2018
Primary outcome: Primary: Feasibility of IVIG Treatment — 23 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Intravenous immunoglobulin (IVIG) (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of IVIG Treatment |
23 | — |
| PRIMARY Acceptability of IVIG |
23 | — |
| PRIMARY Serious Adverse Events |
26 | — |
| PRIMARY Level 3-5 Toxicity |
26 | — |
| PRIMARY Adverse Events |
8 | — |
| SECONDARY Good Bile Drainage at 90 Days Post-HPE |
11 | 0.5486 |
| SECONDARY Good Bile Drainage at 180 Days Post-HPE |
14 | 0.8455 |
| SECONDARY Good Bile Drainage at 360 Days Post-HPE |
7 | 0.8431 |
| SECONDARY Transplant-free Survival |
17 | — |
| SECONDARY Circulating Regulatory T-Cells, Inflammatory Cytokines, and Specific Autoantibodies. |
— | — |
Summary
The Children Liver Disease Research and Education Network (ChiLDREN) is conducting a clinical trial to determine the feasibility, acceptability, tolerability and safety profile of IVIG treatment administered to infants after hepatic portoenterostomy (HPE) for biliary atresia, as well as investigate preliminary evidence of activity and explore mechanisms of action.
Eligibility Criteria
Inclusion Criteria
- Infant under 120 days old with established diagnosis of BA. Subjects in this trial must start treatment within 3-5 days of the Kasai procedure and be part of a prospective study of the natural history of biliary atresia also being conducted by ChiLDREN (http://www.clinicaltrials.gov/ct/show/NCT00061828?order=3).
- Standard HPE operation has been performed for BA within the previous 3 days
- Post-conception age ≥ 36 weeks at time of enrollment
- Weight at enrolment ≥ 2000 gm
- Written informed consent to participate in the study obtained within 3 days of completion of HPE.
Exclusion Criteria
- Laparoscopic HPE or "gall bladder Kasai" (cholecysto-portostomy) surgery was performed
- Biliary atresia splenic malformation syndrome (presence of asplenia, polysplenia or double spleen)
- History of a hypercoagulable disorder
- Renal Disease defined as serum creatinine > 1.0 mg/dl prior to enrollment or presence of complex renal anomalies found on imaging
- Evidence of congestive heart failure or fluid overload
- Presence of significant systemic hypertension for age (defined as persistent systolic blood pressure ≥112 mmHg measured on at least 3 occasions following HPE)
- Infants whose mother is known to have human immunodeficiency virus infection
- Infants whose mother is known to be serum HBsAg or hepatitis C virus antibody positive
- Previous treatment with intravenous immunoglobulin therapy or corticosteroid therapy
- Previous treatment with any other investigational agent
- History of allergic reaction to any human blood product infusion
- Infants with other severe concurrent illnesses, such as neurological, cardiovascular, pulmonary, metabolic, endocrine, and renal disorders, that would interfere with the conduct and results of the study
- Any other clinical condition that is a contraindication to the use of IVIG
Data sourced from ClinicalTrials.gov (NCT01854827). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.