Trial · NCT07477587
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | pharmacokinetic (PK) similarity | 7 days | Area under the serum concentration-time curve from time 0 to day 7 (AUC0-7d) after the 1st dose. |
| Primary | pharmacokinetic (PK) similarity | 7 days | The maximum (peak) serum drug concentration (Cmax) after the 1st dose. |
| Primary | pharmacokinetic (PK) similarity | 16 weeks | Area under the serum concentration-time curve within a dosing interval at steady-state (AUCss) after the 12th dose |
| Primary | pharmacokinetic (PK) similarity | 16 weeks | The maximum (peak) serum drug concentration at steady-state (Cmax,ss) after the 12th dose |
| Secondary | PK characteristics | 16 weeks | trough concentration (Ctrough) |
| Secondary | PK characteristics | 16 weeks | trough concentration at steady state (Ctrough,ss). |
| Secondary | Safety: Adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) | 16 weeks | Adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) terms and frequency of occurrence judged by investigators |
| Secondary | Safety: Vital Signs | 16 weeks | Vital Signs: including blood pressure (systolic and diastolic; mmHg) , pulse rate (beats/min) measured by hematomanometer |
| Secondary | Safety: Vital Signs | 16 weeks | including body temperature (°C) measured by clinical thermometer |
| Secondary | Safety: Physical examinations | 16 weeks | Physical examinations: includes general condition; head and neck; mucous membranes; chest; abdomen; spine; extremities; musculoskeletal system; neurological system; lymphatic system; and skin checked by investigators |
| Secondary | Safety: Laboratory tests | 16 weeks | Laboratory tests: include hematology, blood chemistry, and urinalysis measured by the department of medical laboratory in site |
| Secondary | Safety: Electrocardiography | 16 weeks | Electrocardiography: 12-lead ECG will be performed by qualified personnel using an ECG machine, includes heart rate（beats per minute ） |
| Secondary | Safety: Electrocardiography | 16 weeks | Electrocardiography: 12-lead ECG will be performed by qualified personnel using an ECG machine, includes PR interval（msec）. |
| Secondary | Safety: Electrocardiography | 16 weeks | Electrocardiography: 12-lead ECG will be performed by qualified personnel using an ECG machine, includes QRS duration (msec). |
| Secondary | Safety: Electrocardiography | 16 weeks | Electrocardiography: 12-lead ECG will be performed by qualified personnel using an ECG machine, includes QTc interval (msec). |
| Secondary | Immunogenicity: | 16 weeks | Incidence of anti-drug antibodies (ADA) and neutralizing antibodies (NAb) against the study products (HLX15-SC and US-DARZALEX FASPRO®) and hyaluronidase. |
| Secondary | Efficacy:ORR | 16 weeks | Investigator-assessed overall response rate (ORR): is defined as the percentage of all patients achieving a PR or better after the randomization date. |
| Secondary | Efficacy: partial response (PR) rate | 16 weeks | Partial response (PR) rate is defined as the percentage of all patients achieving a PR at any time point after the randomization date |
| Secondary | Efficacy: very good partial response (VGPR) rate | 16 weeks | Very good partial response (VGPR) rate is defined as the percentage of all patients achieving a VGPR at any time point after the randomization date. |
| Secondary | Efficacy: complete response (CR) rate | 16 weeks | Complete response (CR) rate is defined as the percentage of all patients achieving a CR at any time point after the randomization date. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT07477587/registered