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Completed

NCT Number: NCT00149890

Efficacy and Safety of Basiliximab, Cyclosporine/Cyclosporine Microemulsion, and Steroids in Pediatric de Novo Liver Transplant Recipients Avoiding Intraoperative Steroids

Systemic infection is still a major concern in young children with liver transplantation. The approach of this study is to reduce the risk of systemic infections by avoiding intraoperative steroids (another class of immunosuppressive drugs) given in combination with basiliximab, cyclosporine and steroids in pediatric de novo liver transplant recipients. The treatment is compared to the same treatment regimen including intraoperative steroids with respect to rejection episodes.

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Key information

Conditions

Liver Transplantation Infection Infections

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigational Site

Various Cities, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pediatric patients undergoing primary orthotopic liver transplantation (whole organ or split liver or reduced size)
  • Cadaveric or living donor (related or unrelated)

Exclusion criteria

  • Patients who are recipients of multiple solid organ transplants and/or who have previously received transplanted organs
  • If cold ischemia time of the transplanted organ is >12 hours
  • Auxiliary liver transplant recipients
  • Fulminant hepatic failure
  • Autoimmune hepatitis
  • Primary sclerosing cholangitis
  • Severe acute systemic infections
  • Hepatitis B surface antigen/HCV/HIV positive
  • Known contraindication to intravenous (i.v.) or per os (orally) (p.o.) cyclosporine or corticoids
  • Non-ability to comply with the protocol
  • Relevant abnormal physical or laboratory findings within 2 weeks of inclusion
  • Relevant severe allergy, hypersensitivity to basiliximab or similar drugs
  • History/presence of relevant malignancy
  • Pregnancy/breastfeeding
  • Use of any investigational or immunomodulatory/immunosuppressive drug within 4 weeks prior to transplantation.

Treatment and study plan

Basiliximab

Drug

Basiliximab (10 mg) was supplied as a lyophilisate in vials with ampoules of sterile water for injection (5 mL) and had to be given of 10 mg (body weight <35 kg) or 20 mg (body weight ≥35 kg) strength.

Other names: Simulect®

Cyclosporine/cyclosporine microemulsion

Drug

Cyclosporine/cyclosporine microemulsion had to be started with 100 mg/m²/day intravenous (i.v) (2x4h) for 7 days and was to be continued i.v. or orally from day 8 onwards as per center practice. During the 6 months treatment period Cyclosporine doses had to be adjusted according to Cyclosporine A (CsA)-trough levels.

Other names: Sandimmun®/Sandimmun® Optoral

Steroid

Drug

Intravenous prednisolone (loading dose: 300 mg/m2, maximum 500 mg) had to be administered intraoperatively only in treatment arm 1 (day 0). The first dose of steroids in treatment arm 2 (day 0) had to be administered within 8 hours after reperfusion of the graft. Beginning from day 1 to day 6 doses of 15 mg/m2/day had to be given intravenously (i.v.) in both treatment arms. Then, the steroid doses (oral prednisone or its equivalent) were to be decreased from 10 mg/m²/day orally (day 7-13), to 7.5 mg/m²/day orally (day 14-30), to 4 mg/m²/day orally (until end of month 2), to 2.5 mg/m²/day orally (until end of month 3) and to 1 mg/m²/day orally (until end of month 6).

Primary outcomes

  1. Number of Participants With at Least One Biopsy Proven Acute Rejection (BPAR) Episode, Graft Loss or Death Within the First Three Months Post-transplantation

    Time frame: 3 months after treatment

    Graft loss is defined as being listed for a re-transplantation. The analysis was based on the locally performed biopsy assessments. Generally, patients not experiencing a relevant event (i.e., acute rejection, graft loss or death) were censored with the last visit date.

Secondary outcomes

  1. Number of Participants With Biopsy Proven Acute Rejection (BPAR) Episodes Within the First Three Months

    Time frame: 3 months

    At biopsy of transplanted tissue sample, acute rejection has an onset 2-60 days after transplantation, with interstitial vascular endothelial cell swelling, interstitial accumulation of lymphocytes, plasma cells, immunoblasts, macrophages, neutrophils; tubular separation with edema/necrosis of tubular epithelium; swelling and vacuolization of the endothelial cells, vascular edema, bleeding and inflammation. Clinical signs and symptoms include malaise, fever, and hypertension.

  2. Number of Participants With Steroid Resistant Rejection Episodes Within Three and Six Months

    Time frame: 3 and 6 months

    To evaluate the efficacy of a regimen with intraoperative versus without intraoperative steroids in combination with basiliximab, cyclosporine/cyclosporine microemulsion and steroids as measured by the incidence of steroid resistant rejection episodes within three and six months.

  3. Percentage of Participants Experiencing Death or Graft Loss Within Three and Six Months After Transplantation

    Time frame: 3 months and 6 months

    Graft loss is defined as being listed for a re-transplantation.

  4. Number of Participants With Bacterial, Viral and Fungal Infections During Six Months

    Time frame: 6 months

    To evaluate the safety of a regimen with intraoperative versus without intraoperative steroids in combination with basiliximab, cyclosporine/cyclosporine microemulsion and steroids as measured by the episodes of bacterial, viral and fungal infections during six months.

  5. Time of Onset of a First Biopsy Proven Acute Rejection

    Time frame: 6 months

    Biopsied Tissue shows rejection at onset 2-60 days after transplantation, with interstitial vascular endothelial cell swelling, interstitial accumulation of lymphocytes, plasma cells, immunoblasts, macrophages, neutrophils; tubular separation with edema/necrosis of tubular epithelium; swelling and vacuolization of the endothelial cells, vascular edema, bleeding and inflammation. Clinical signs and symptoms include malaise, fever and hypertension

    .

  6. Percentage of Participants With Treatment Failure Within Three and Six Months

    Time frame: 3 and 6 months

    To evaluate the proportion of patients with treatment failure treated with a therapy consisting of intraoperative versus without intraoperative steroids in combination with basiliximab, cyclosporine/cyclosporine microemulsion and steroids within three and six months.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A Multicenter, Open-label, Randomized, Two Arm Study to Investigate the Efficacy and Safety of a Therapy Avoiding Intraoperative Steroids in Combination With Basiliximab, Cyclosporine/Cyclosporine Microemulsion, and Steroids in Pediatric de Novo Liver Transplant Recipients

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Sep 8, 2005
Registry last updated
Sep 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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