Trial · NCT01175213
Outcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Annual Rate of Serious Bacterial Infections | Throughout the efficacy period only (from 60 to 729 days) | Safety Analysis Set excluding the 3 participants who were treated with intravenous (IV) administration of IGSC, 10% without rHuPH20 | Estimated infections/year | NUMBER |
| PRIMARY | Annual Rate of All Infections | Throughout the efficacy period only (from 60 to 729 days) | Safety Analysis Set excluding the 3 participants who were treated with intravenous (IV) administration of IGSC, 10% without rHuPH20 | Number of infections/year | NUMBER |
| PRIMARY | Trough Levels of IgG Maintained During the Study Period in Relation to Dose Frequency | Throughout the efficacy period only (from 60 to 729 days) | Safety Analysis Set | g/L | MEDIAN |
| SECONDARY | The Annual Rate of Serious Adverse Events (SAEs), Related and Not Related to Study Drugs | Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer. | Safety Analysis Set | SAEs/year | NUMBER |
| SECONDARY | Percentage of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for AEs | Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer. | Safety Analysis Set | Percentage of infusions | NUMBER |
| SECONDARY | Percentage of Infusions Associated With One or More Moderate or Severe AEs (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of an Infusion | Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer. | Safety Analysis Set | Percentage of infusions | NUMBER |
| SECONDARY | Number of Participants Who Develop Antibodies and Neutralizing Antibodies to rHuPH20 | Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months) | Participants from study 160603 and this study (160902) who have received at least one infusion of rHuPH20 | Number of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Develop Antibodies and Neutralizing Antibodies to rHuPH20 | Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months) | Participants from study 160603 and this study (160902) who have received at least one infusion of rHuPH20 | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With AEs Related to Anti-rHuPH20 Titers | Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months) | All participants who had been exposed to recombinant human hyaluronidase (rHuPH20) in studies 160603 or 160902. | Number of participants | NUMBER |
| SECONDARY | Percentage of Participants With AEs Related to Anti-rHuPH20 Titers | Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months) | All participants who had been exposed to recombinant human hyaluronidase (rHuPH20) in studies 160603 or 160902. | Percentage of participants | NUMBER |
| SECONDARY | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). | Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer. | Safety Analysis Data Set | Number of AEs | NUMBER |
| SECONDARY | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). | Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer. | Safety Analysis Data Set | Number of AEs | NUMBER |
| SECONDARY | Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). | Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer. | Safety Analysis Data Set | Number of AEs | NUMBER |
| SECONDARY | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer. | Safety Analysis Data Set | Number of AEs per participant | NUMBER |
| SECONDARY | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer. | Safety Analysis Data Set | Number of AEs per participant | NUMBER |
| SECONDARY | Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer. | Safety Analysis Data Set | Number of AEs per participant | NUMBER |
| SECONDARY | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). | Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer. | Safety Analysis Data Set | Number of AEs per infusion | NUMBER |
| SECONDARY | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). | Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer. | Safety Analysis Data Set | Number of AEs per infusion | NUMBER |
| SECONDARY | Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). | Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer. | Safety Analysis Data Set | Number of AEs per infusion | NUMBER |
| SECONDARY | Rate of AEs Per Participant (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (Related) | Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer. | Safety Analysis Data Set | Number of AEs per participant | NUMBER |
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.
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