Clinical Trials List
Protocol NumberCCSJ148X2201
NCT Number(ClinicalTrials.gov Identfier)NCT02268526
2015-06-01 - 2017-09-30
Phase II
Terminated3
ICD-9078.5
Cytomegaloviral disease
A multi-center, randomized, double-blind, placebo controlled, study to evaluate the efficacy and safety of CSJ148 compared to placebo to prevent human cytomegalovirus (HCMV) replication in stem cell transplant patients
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Trial Applicant
NOVARTIS (TAIWAN) CO., LTD.
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Sponsor
Novartis Pharmaceuticals
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Li-Yuan Bai Division of Hematology & Oncology
- Ming-Yu Lien Division of Hematology & Oncology
- Ching Yun Hsieh Division of Hematology & Oncology
- Che-Hung Lin Division of Hematology & Oncology
- Tzu-Ting Chen Division of Hematology & Oncology
- Chen-Yuan Lin Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- Ming-Chung Kao Division of Hematology & Oncology
- Tung-Liang Lin Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
Co-Principal Investigator
- 李啟誠 Division of General Internal Medicine
- Chien-Chin Lin Division of General Internal Medicine
- Huai-Hsuan Huang Division of General Internal Medicine
- 徐思淳 Division of General Internal Medicine
- 林建廷 Division of General Internal Medicine
- Tai-Chung Huang Division of General Internal Medicine
- MING YAO Division of General Internal Medicine
- CHENG-HONG TSAI Division of General Internal Medicine
- Sheng-chieh Chou Division of General Internal Medicine
- 劉家豪 Division of General Internal Medicine
- Chieh-Lung Cheng Division of General Internal Medicine
- - - Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
Condition/Disease
prevent human cytomegalovirus (HCMV) replication in stem cell transplant patients
Objectives
The purpose of this study is to assess the efficacy of CSJ148 on preventing active
HCMV infection during the first 98 days after stem cell transplant as well as the safety and
tolerability of CSJ148 when administered to stem cell transplant recipients
Test Drug
CSJ148
Active Ingredient
(consists two fully human IgG1 anti-HCMV monoclonal antibodies, LJP538 and LJP539)
Dosage Form
LJP538 liquid in vial; LJP539 lyohilized in vial
Dosage
LJP538-150mg/ml; LJP539-50mg/ml
Endpoints
1. Primary endpoint:
To assess the efficacy of CSJ148 on preventing active HCMV infection during the first 98
days after stem cell transplant.
To assess the safety and tolerability of CSJ148 when administered to stem cell transplant
recipients.
2. Secondary endpoints:
To assess if CSJ148 can increase the time to start preemptive therapy.
To assess if CSJ148 can reduce the number of times that preemptive therapy is required.
To assess if CSJ148 can reduce the proportion of patients developing HCMV disease.
To assess the PK of CSJ148 in stem cell transplant recipients.
To assess the efficacy of CSJ148 on preventing active HCMV infection during the first 98
days after stem cell transplant.
To assess the safety and tolerability of CSJ148 when administered to stem cell transplant
recipients.
2. Secondary endpoints:
To assess if CSJ148 can increase the time to start preemptive therapy.
To assess if CSJ148 can reduce the number of times that preemptive therapy is required.
To assess if CSJ148 can reduce the proportion of patients developing HCMV disease.
To assess the PK of CSJ148 in stem cell transplant recipients.
Inclution Criteria
Main inclusion criteria:
Patients eligible for inclusion in this study have to fulfill all of the following criteria:
1. Written informed consent must be obtained before any assessment is performed.
2. Male and female patients at least 20 years of age.
3. Patients must weigh between 45 -120 kg to participate in the study, and must have a body
mass index (BMI) within the range of 18 - 34 kg/m2
4. Scheduled to undergo allogeneic bone marrow, peripheral blood stem cell, or cord blood
transplantation (transplant may be related or unrelated, T-cell depleted or non-T-cell
depleted, myeloablative or non-myeloablative/reduced intensity, haploidentical) and begin
conditioning chemotherapy within 24-48 hours of planned dosing day.
5. Patient seropositive for HCMV before transplantation; donor can be seropositive or
seronegative for HCMV (donor positive/recipient positive or donor negative/recipient
positive). Historical patient HCMV serology data collected within the last 12 months or
local assays may be used to qualify the patient for enrollment.
6. Able to communicate well with the investigator, to understand and comply with the
requirements of the study.
Patients eligible for inclusion in this study have to fulfill all of the following criteria:
1. Written informed consent must be obtained before any assessment is performed.
2. Male and female patients at least 20 years of age.
3. Patients must weigh between 45 -120 kg to participate in the study, and must have a body
mass index (BMI) within the range of 18 - 34 kg/m2
4. Scheduled to undergo allogeneic bone marrow, peripheral blood stem cell, or cord blood
transplantation (transplant may be related or unrelated, T-cell depleted or non-T-cell
depleted, myeloablative or non-myeloablative/reduced intensity, haploidentical) and begin
conditioning chemotherapy within 24-48 hours of planned dosing day.
5. Patient seropositive for HCMV before transplantation; donor can be seropositive or
seronegative for HCMV (donor positive/recipient positive or donor negative/recipient
positive). Historical patient HCMV serology data collected within the last 12 months or
local assays may be used to qualify the patient for enrollment.
6. Able to communicate well with the investigator, to understand and comply with the
requirements of the study.
Exclusion Criteria
Main exclusion criteria:
Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
1. Use of other investigational drugs at the time of enrollment, or within 5 half-lives of
enrollment, or until the expected PD effect has returned to baseline, whichever is longer; or
longer if required by local regulations.
2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
3. Karnofsky performance score < 50%
4. Have had HCMV-related organ disease within 6 months prior to enrollment.
5. Detectable HCMV infection (positive pp65 antigenemia or plasma HCMV DNA polymerase
chain reaction (PCR) assays prior to enrollment from samples collected within 5 days prior
to enrollment. Local assays may be used to qualify the patient for enrollment.
6. Received any of the following within 30 days prior to enrollment: ganciclovir,
valganciclovir, foscarnet, cidofovir, acyclovir (>25 mg/kg/day IV), valacyclovir (>3 gm/day
oral), famciclovir (>1500 mg/day oral), HCMV immune globulin, immune globulin (>500
mg/kg), or any other medication with anti-HCMV activity.
7. Require mechanical ventilation within 7 days prior to enrollment.
8. Received any vasopressors or other agents for hemodynamic support within 7 days prior to
enrollment. These agents include but are not limited to epinephrine, metaraminol,
norepinephrine, dopamine, vasopressin, phenylephrine, and dobutamine.
9. Impaired renal function requiring dialysis.
10. Any surgical or medical condition which might increase the risk for thrombotic events if
given immunoglobulins. These conditions include cryoglobulinemia, monoclonal
gammopathies, and hypertriglyceridemia (fasting level >1000 mg/dL). The investigator
should make this determination in consideration of the subject’s medical history and
laboratory data.
11. Severe liver disease or liver injury as indicated one or more of the following:
Alanine aminotransferase (ALT) >3-times the upper limit of normal.
Aspartate aminotransferase (AST) >3-times the upper limit of normal.
Gamma-glutamyl transferase (γ-GT) >5-times the upper limit of normal.
Serum total bilirubin (TBL) >1.5-times the upper limit of normal.
12. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female
after conception and until the termination of gestation, confirmed by a positive human
chorionic gonadotropin (hCG) laboratory test.
13. Women of child-bearing potential, defined as all women physiologically capable of
becoming pregnant, unless they are using effective methods of contraception during dosing
of study treatment. Effective contraception methods include:
Total abstinence (when this is in line with the preferred and usual lifestyle of the
subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation
methods) and withdrawal are not acceptable methods of contraception.
Female sterilization (have had surgical bilateral oophorectomy with or without
hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case
of oophorectomy alone, only when the reproductive status of the woman has been
confirmed by follow up hormone level assessment.
Male sterilization (at least 6 months prior to screening). For female patients on the
study, the vasectomized male partner should be the sole partner for that subject.
Barrier methods of contraception: Condom or Occlusive cap (diaphragm or
cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository.
Use of oral, injected or implanted hormonal methods of contraception or other forms of
hormonal contraception that have comparable efficacy (failure rate <1%), for example
hormone vaginal ring or transdermal hormone contraception.
Placement of an intrauterine device (IUD) or intrauterine system (IUS).
In case of use of oral contraception women should have been stable on the same pill for a
minimum of 3 months before taking study treatment.
Women are considered post-menopausal and not of child bearing potential if they have had
12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age
appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy
(with or without hysterectomy) or tubal ligation at least six weeks ago. In the case of
oophorectomy alone, only when the reproductive status of the woman has been confirmed
by follow up hormone level assessment is she considered not of child bearing potential.
14. History of positive HIV (ELISA and Western blot) test result. Testing is not required.
No additional exclusions may be applied by the investigator, in order to ensure that the study
population will be representative of all eligible patients.
Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
1. Use of other investigational drugs at the time of enrollment, or within 5 half-lives of
enrollment, or until the expected PD effect has returned to baseline, whichever is longer; or
longer if required by local regulations.
2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
3. Karnofsky performance score < 50%
4. Have had HCMV-related organ disease within 6 months prior to enrollment.
5. Detectable HCMV infection (positive pp65 antigenemia or plasma HCMV DNA polymerase
chain reaction (PCR) assays prior to enrollment from samples collected within 5 days prior
to enrollment. Local assays may be used to qualify the patient for enrollment.
6. Received any of the following within 30 days prior to enrollment: ganciclovir,
valganciclovir, foscarnet, cidofovir, acyclovir (>25 mg/kg/day IV), valacyclovir (>3 gm/day
oral), famciclovir (>1500 mg/day oral), HCMV immune globulin, immune globulin (>500
mg/kg), or any other medication with anti-HCMV activity.
7. Require mechanical ventilation within 7 days prior to enrollment.
8. Received any vasopressors or other agents for hemodynamic support within 7 days prior to
enrollment. These agents include but are not limited to epinephrine, metaraminol,
norepinephrine, dopamine, vasopressin, phenylephrine, and dobutamine.
9. Impaired renal function requiring dialysis.
10. Any surgical or medical condition which might increase the risk for thrombotic events if
given immunoglobulins. These conditions include cryoglobulinemia, monoclonal
gammopathies, and hypertriglyceridemia (fasting level >1000 mg/dL). The investigator
should make this determination in consideration of the subject’s medical history and
laboratory data.
11. Severe liver disease or liver injury as indicated one or more of the following:
Alanine aminotransferase (ALT) >3-times the upper limit of normal.
Aspartate aminotransferase (AST) >3-times the upper limit of normal.
Gamma-glutamyl transferase (γ-GT) >5-times the upper limit of normal.
Serum total bilirubin (TBL) >1.5-times the upper limit of normal.
12. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female
after conception and until the termination of gestation, confirmed by a positive human
chorionic gonadotropin (hCG) laboratory test.
13. Women of child-bearing potential, defined as all women physiologically capable of
becoming pregnant, unless they are using effective methods of contraception during dosing
of study treatment. Effective contraception methods include:
Total abstinence (when this is in line with the preferred and usual lifestyle of the
subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation
methods) and withdrawal are not acceptable methods of contraception.
Female sterilization (have had surgical bilateral oophorectomy with or without
hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case
of oophorectomy alone, only when the reproductive status of the woman has been
confirmed by follow up hormone level assessment.
Male sterilization (at least 6 months prior to screening). For female patients on the
study, the vasectomized male partner should be the sole partner for that subject.
Barrier methods of contraception: Condom or Occlusive cap (diaphragm or
cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository.
Use of oral, injected or implanted hormonal methods of contraception or other forms of
hormonal contraception that have comparable efficacy (failure rate <1%), for example
hormone vaginal ring or transdermal hormone contraception.
Placement of an intrauterine device (IUD) or intrauterine system (IUS).
In case of use of oral contraception women should have been stable on the same pill for a
minimum of 3 months before taking study treatment.
Women are considered post-menopausal and not of child bearing potential if they have had
12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age
appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy
(with or without hysterectomy) or tubal ligation at least six weeks ago. In the case of
oophorectomy alone, only when the reproductive status of the woman has been confirmed
by follow up hormone level assessment is she considered not of child bearing potential.
14. History of positive HIV (ELISA and Western blot) test result. Testing is not required.
No additional exclusions may be applied by the investigator, in order to ensure that the study
population will be representative of all eligible patients.
The Estimated Number of Participants
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Taiwan
15 participants
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Global
86 participants
