NCT02268526

Brief Summary

This study is designed to test if CSJ148 can prevent HCMV replication after stem cell transplantation.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2015

Shorter than P25 for phase_2

Geographic Reach
6 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 20, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

June 2, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2016

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

February 26, 2018

Completed
Last Updated

January 5, 2021

Status Verified

March 1, 2019

Enrollment Period

1.5 years

First QC Date

August 8, 2014

Results QC Date

December 6, 2017

Last Update Submit

December 9, 2020

Conditions

HCMV

Keywords

Safety, efficacy, pharmacokinetics, CSJ148, HCMV, HCMV viral load,immunogenicity

Outcome Measures

Primary Outcomes (2)

  • Number of Participants Who Require Preemptive HCMV Therapy

    Number of participants who require preemptive HCMV therapy. The definition of requiring preemptive anti-HCMV therapy was meeting either one of the following conditions: 1. the plasma HCMV DNA level is \>= 1000 copies/mL (with or without HCMV disease) or 2. the plasma HCMV DNA level is \< 1000 copies/mL, but HCMV disease was reported

    98 days

  • Number of Participants With Adverse Events as a Measure of Safety and Tolerability

    Number of participants with adverse events as a measure of safety and tolerability. Patients treated with CSJ148 in Cohorts 1 and 2 were pooled to simplify the safety analyses.

    98 days

Secondary Outcomes (9)

  • Time to Start of Preemptive HCMV Therapy Cohort 2

    98 days

  • Number of Times That Preemptive HCMV Therapy is Required -Cohort 2

    98 days

  • Proportion of Participants Developing HCMV Disease

    98 days

  • Area Under the Serum Concentration-time Curve During the Dosing Interval (AUCtau) for CSJ148 Only

    Day 1, Day 29, Day 57, Day 85 at predose (0hr) and 3,6,24 hrs post dose

  • Maximum Serum Concentration During the Dosing Interval (Cmax) for CSJ148 Only

    Day 1, Day 29, Day 57, Day 85 at predose (0hr) and 3,6,24 hrs post dose

  • +4 more secondary outcomes

Study Arms (3)

Cohort 1: CSJ148

EXPERIMENTAL

Cohort 1: CSJ148 IV q 4weeks

Biological: CSJ148

Cohort 2: CSJ148

EXPERIMENTAL

Cohort 2: CSJ148 IV q 4weeks

Biological: CSJ148

Cohort 2: Placebo

PLACEBO COMPARATOR

Cohort 2: Placebo IV q 4weeks

Drug: Placebo

Interventions

CSJ148BIOLOGICAL

CSJ148 IV q 4weeks

Cohort 1: CSJ148Cohort 2: CSJ148
PlaceboDRUG

Placebo IV q 4weeks

Cohort 2: Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent must be obtained before any assessment was performed.
  • Male and female patients at least 18 years of age.
  • Patients weighed between 45 -120 kg to participate in the study, and had a body mass index (BMI) within the range of 18 - 34 kg/m2
  • 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 began conditioning chemotherapy within 48 hours of planned dosing day.
  • Patient seropositive for HCMV before transplantation; donor could be seropositive or seronegative for HCMV (donor positive/recipient or donor negative/recipient positive). Historical patient HCMV serology data collected within the last 12 months or local assays could be used to qualify the patient for enrollment.
  • Able to communicate well with the investigator, to understand and comply with the requirements of the study.

You may not qualify if:

  • Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or until the expected PD (pharmacodynamic) effect has returned to baseline, whichever is longer; or longer if required by local regulations.
  • History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
  • Karnofsky performance score \<50%.
  • Had HCMV-related organ disease within 6 months prior to enrollment.
  • Detectable HCMV infection (positive pp65 antigenemia or plasma HCMV DNA polymerase chain reaction (PCR) assays prior to enrollment from samples collected within 14 days prior to enrollment. Local assays could be used to qualify the patient for enrollment.
  • 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.
  • Required mechanical ventilation within 7 days prior to enrollment.
  • Received any vasopressors or other agents for hemodynamic support within 7 days prior to enrollment. These agents included but are not limited to epinephrine, metaraminol, norepinephrine, dopamine, vasopressin, phenylephrine, and dobutamine.
  • Impaired renal function requiring dialysis.
  • Any surgical or medical condition which might increase the risk for thrombotic events if given immunoglobulins. These conditions included 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.
  • Severe liver disease or liver injury as indicated one or more of the following:
  • Alanine aminotransferase (ALT) \>5-times the upper limit of normal (ULN).
  • Aspartate aminotransferase (AST) \>5-times the upper limit of normal.
  • Gamma-glutamyl transferase (γ-GT) \>5-times the upper limit of normal.
  • Serum total bilirubin (TBL) \>3-times the upper limit of normal.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Novartis Investigative Site

San Francisco, California, 94143, United States

Location

Novartis Investigative Site

Gainesville, Florida, 32610, United States

Location

Novartis Investigative Site

Beech Grove, Indiana, 46107, United States

Location

Novartis Investigative Site

Durham, North Carolina, 27710, United States

Location

Novartis Investigative Site

Houston, Texas, 77030, United States

Location

Novartis Investigative Site

Leuven, 3000, Belgium

Location

Novartis Investigative Site

Erlangen, 91054, Germany

Location

Novartis Investigative Site

Essen, 45147, Germany

Location

Novartis Investigative Site

Regensburg, 93053, Germany

Location

Novartis Investigative Site

Würzburg, 97070, Germany

Location

Novartis Investigative Site

Singapore, 119228, Singapore

Location

Novartis Investigative Site

Singapore, 169608, Singapore

Location

Novartis Investigative Site

Seoul, Korea, 06351, South Korea

Location

Novartis Investigative Site

Seoul, 06591, South Korea

Location

Novartis Investigative Site

New Taipei City, 33305, Taiwan

Location

Novartis Investigative Site

Taichung, 40447, Taiwan

Location

Novartis Investigative Site

Taipei, 10002, Taiwan

Location

Related Publications (1)

  • Maertens J, Logan AC, Jang J, Long G, Tang JL, Hwang WYK, Koh LP, Chemaly R, Gerbitz A, Winkler J, Yeh SP, Hiemenz J, Christoph S, Lee DG, Wang PN, Holler E, Mielke S, Akard L, Yeo A, Ramachandra S, Smith K, Pertel P, Segal F. Phase 2 Study of Anti-Human Cytomegalovirus Monoclonal Antibodies for Prophylaxis in Hematopoietic Cell Transplantation. Antimicrob Agents Chemother. 2020 Mar 24;64(4):e02467-19. doi: 10.1128/AAC.02467-19. Print 2020 Mar 24.

    PMID: 32015031DERIVED

Related Links

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
8627788300

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2014

First Posted

October 20, 2014

Study Start

June 2, 2015

Primary Completion

December 7, 2016

Study Completion

December 7, 2016

Last Updated

January 5, 2021

Results First Posted

February 26, 2018

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will share

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Locations

DE(4)BE(1)US(5)SG(2)KR(2)TW(3)