Trial · NCT01928030
Recombinant Human Hyaluronidase in Treating Lymphedema in Patients With Cancer
NCT01928030, Phase 1, Phase 2, Terminated, Stanford University; results first posted 2017-02-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Recombinant Human Hyaluronidase in Treating Lymphedema in Patients With Cancer. Trials, record NCT01928030. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01928030
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Recombinant Human Hyaluronidase in Treating Lymphedema in Patients With Cancer
- NCT number
- NCT01928030
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 3 participants, actual
- Lead sponsor
- Stanford University
- Conditions
- Lymphedema, Malignant Neoplasm
- Interventions
- recombinant human hyaluronidase
- First posted
- 2013-08-23
- Last updated
- 2017-03-21
- Results first posted
- 2017-02-07
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment-related Adverse Events | Up to 1 year | Reported as any untoward medical occurrence or worsening of a pre-existing medical condition in a participant administered recombinant human hyaluronidase, and judged possibly, probably, or definitely related to treatment |
| Secondary | Reduction in Forearm Volume | Up to 1 year | Number of patients that achieve a clinically significant reduction in lymphedema, assessed as a 20% reduction in excess forearm volume |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Treatment-related Adverse Events | Up to 1 year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Reduction in Forearm Volume | Up to 1 year | No participants received 900 units rHuPH20, and the MTD was not determined, so no participants received rHuPH20 at the MTD. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Treatment-related Adverse Events | 450 Units Recombinant Human Hyaluronidase (rHuPH20) | 1 | Participants | ||
| Reduction in Forearm Volume | 450 Units rHuPH20 (Days 1, 3, 5, and 7) | 0 | Participants | ||
| Reduction in Forearm Volume | 900 Units rHuPH20 (Days 1, 3, 5, and 7) | 0 | Participants | ||
| Reduction in Forearm Volume | MTD rHuPH20 (Days 1 to 21) | 0 | Participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 450 Units rHuPH20 (Days 1, 3, 5, and 7) | 3 | |
| Overall Study | STARTED | 900 Units rHuPH20 (Days 1, 3, 5, and 7) | 0 | |
| Overall Study | STARTED | MTD rHuPH20 (Days 1 to 21) | 0 | |
| Overall Study | COMPLETED | 450 Units rHuPH20 (Days 1, 3, 5, and 7) | 3 | |
| Overall Study | COMPLETED | 900 Units rHuPH20 (Days 1, 3, 5, and 7) | 0 | |
| Overall Study | COMPLETED | MTD rHuPH20 (Days 1 to 21) | 0 | |
| Overall Study | NOT COMPLETED | 450 Units rHuPH20 (Days 1, 3, 5, and 7) | 0 | |
| Overall Study | NOT COMPLETED | 900 Units rHuPH20 (Days 1, 3, 5, and 7) | 0 | |
| Overall Study | NOT COMPLETED | MTD rHuPH20 (Days 1 to 21) | 0 |
Source ClinicalTrials.gov
Adverse events1
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Erythema (injection site reaction) | Skin and subcutaneous tissue disorders | Recombinant Human Hyaluronidase | 1 | 3 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Recombinant Human Hyaluronidase | ||
| Total, other adverse events | Recombinant Human Hyaluronidase | 1 | 3 |
| Total, serious adverse events | Recombinant Human Hyaluronidase | 0 | 3 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA124435 | Stanford Cancer Institute | ARTANDI, STEVEN E | STANFORD UNIVERSITY | NATIONAL CANCER INSTITUTE | 2007 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01928030
GET https://conductscience.org/api/trials/v1/NCT01928030/registered