18 and older, any sex, with Chemotherapy-induced Neutropenia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Double-Blind Phase: Duration of Severe Neutropenia in Cycle 1Primary· Cycle 1 (cycle length = 21 days)
Severe neutropenia was defined as Grade 4 neutropenia (absolute neutrophil count \[ANC\] \<0.5 x 10\^9/liter \[L\]). The duration of severe neutropenia was calculated by cycle as the number of days from the first day in which the ANC fell below 0.5 x 10\^9/L after beginning a chemotherapy cycle until the participant had an ANC ≥0.5 x 10\^9/L within the cycle.
Group
Value
95% CI
Double-Blind Phase: Pegfilgrastim
1.0
± 1.08
Double-Blind Phase: Neugranin 40 mg
1.1
± 1.13
Double-Blind Phase: Number of Participants With Febrile NeutropeniaSecondary· Cycles 1-4 (each cycle = 21 days)
Febrile neutropenia was defined as an imputed or observed ANC \<0.5 x 10\^9/L and body temperature \>38.5 degrees celsius (°C) occurring on the same day and for more than one hour (axillary measurement). Number of participants with febrile neutropenia over all cycles (Cycles 1 to 4) has been reported.
Group
Value
95% CI
Double-Blind Phase: Pegfilgrastim
4
Double-Blind Phase: Neugranin 40 mg
2
Open-Label Phase: Duration of Severe Neutropenia in Cycle 1Primary· Cycle 1 (cycle length = 21 days)
Severe neutropenia was defined as Grade 4 neutropenia (ANC \<0.5 x 10\^9/L). The duration of severe neutropenia was calculated by cycle as the number of days from the first day in which the ANC fell below 0.5 x 10\^9/L after beginning a chemotherapy cycle until the participant had an ANC ≥0.5 x 10\^9/L within the cycle. There was no planned statistical analysis for the open-label phase arm.
Group
Value
95% CI
Open-Label Phase: Neugranin 40 mg
1.0
± 1.03
Open-Label Phase: Number of Participants With Febrile NeutropeniaSecondary· Cycles 1-4 (each cycle = 21 days)
Febrile neutropenia was defined as an imputed or observed ANC \<0.5 x 10\^9/L and body temperature \>38.5 °C occurring on the same day and for more than one hour (axillary measurement). Number of participants with febrile neutropenia over all cycles (Cycles 1 to 4) has been reported.
Group
Value
95% CI
Open-Label Phase: Neugranin 40 mg
2
Adverse events — posted to ClinicalTrials.gov
Time frame: From the start of study drug administration through 30 days following the final dose of study drug (up to 114 days).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Determination of the effect of neugranin on the duration and severity of severe neutropenia in participants receiving doxorubicin in combination with docetaxel.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Teva Branded Pharmaceutical Products R&D, Inc.
Last refreshed: 28 March 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01126190.