Trial · NCT01554956
Efficacy/Safety of Human Plasminogen Eye Drop in Ligneous Conjunctivitis Patients
NCT01554956, Phase 2, Phase 3, Completed, Kedrion S.p.A.; results first posted 2023-01-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy/Safety of Human Plasminogen Eye Drop in Ligneous Conjunctivitis Patients. Trials, record NCT01554956. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01554956
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy/Safety of Human Plasminogen Eye Drop in Ligneous Conjunctivitis Patients
- NCT number
- NCT01554956
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 12 participants, actual
- Lead sponsor
- Kedrion S.p.A.
- Conditions
- Ligneous Conjunctivitis
- Interventions
- Human Plasminogen
- First posted
- 2012-03-15
- Last updated
- 2023-01-25
- Results first posted
- 2023-01-25
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Success to Prevent Pseudomembranes Relapse | The prevention of pseudomembranes relapse was assessed during Segment 2, after initial total regression at the end of Segment 1 (Group 1A) or after surgical excision (Group 1B) up to 21 weeks from the study start. | The primary endpoint (prevention of pseudomembrane relapse) was presented descriptively based on the predefined success levels: complete success (defined as no relapse by the end of Segment 2), partial success(defined as relapse appearing 2 weeks or longer after the start of Segment 2, or if following the 3 rd cycle of Segment 2 for Group 1A no relapse occurred while maintaining the higher dose) or failure (defined as relapse within 2 weeks of the start of Segment 2 or if at repeat cycles of Segment 1 for Group 1A, the pseudomembranes did not regress after Segment 1). Ninety-five percent confidence intervals for the relapse rate (complete success, and complete plus partial success) were calculated on the assumption of a binomial distribution. The responses were tabulated for the mITT and Per Protocol populations. |
| Secondary | Percentage of Eyes With Regression in Surface Area of Existing Ligneous Pseudomembranes | Regression of pseudomembranes surface area (PSA) was assessed from baseline to the end of Segment 1, up to 5 weeks (one subject was assessed after 9 weeks due to the occurrence of a not related SAE - Varicella - between Visit 0 and Visit 1) | The secondary endpoint was presented descriptively based on the predefined success levels: complete success (defined as regression of PSAs \>90%), partial success (defined as regression of PSAs between 20% and 90%) or failure (defined as regression of PSAs \<20%). The responses were tabulated for the mITT and the Per Protocol populations. |
| Other | Number of Subjects Who Experience Signs and Symptoms of Sensitization. | Signs and symptoms of sensitization were evaluated during the Part 1 and Part 2 of the study up to 7 years | The safety parameters were presented descriptively and tabulated for the Group 1A, Group 1B and Continuation Segment safety population. |
| Other | Number of Subjects Who Experience Adverse Events. | AEs were collected from the screening visit and throughout the study up to 7 years | The safety parameters were presented descriptively and tabulated for the Group 1A, Group 1B and Continuation Segment safety population. |
| Other | Number of Subjects Who Develop Antibodies Against Bovine Aprotinin. | The antibody development was detected during Part 1 and Part 2 of the study up to 7 years | The safety parameters were presented descriptively and tabulated for the Group 1A, Group 1B and Continuation Segment safety population. |
| Other | Number of Subjects Who Develop Antibodies Against Human Plasminogen. | The antibody development was detected during the Part 1 and Part 2 of the study, up to 7 years | The safety parameters were presented descriptively and tabulated for the Group 1A, Group 1B and Continuation Segment safety population. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Success to Prevent Pseudomembranes Relapse | The prevention of pseudomembranes relapse was assessed during Segment 2, after initial total regression at the end of Segment 1 (Group 1A) or after surgical excision (Group 1B) up to 21 weeks from the study start. | percentage of eyes | NUMBER | |
| SECONDARY | Percentage of Eyes With Regression in Surface Area of Existing Ligneous Pseudomembranes | Regression of pseudomembranes surface area (PSA) was assessed from baseline to the end of Segment 1, up to 5 weeks (one subject was assessed after 9 weeks due to the occurrence of a not related SAE - Varicella - between Visit 0 and Visit 1) | The first Part of the Study was divided in two segments: Segment 1, where all patients received the same intervention and Segment 2 where, depending on the outcome of Segment 1, patients were assigned to Group 1A (in case of complete pseudomembranes regression) or Group 1B (in case of no or partial pseudomembranes regression), receiving different intervention. | percentage of eyes | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Subjects Who Experience Signs and Symptoms of Sensitization. | Signs and symptoms of sensitization were evaluated during the Part 1 and Part 2 of the study up to 7 years | number of subjects | NUMBER | |
| OTHER_PRE_SPECIFIED | Number of Subjects Who Experience Adverse Events. | AEs were collected from the screening visit and throughout the study up to 7 years | number of subjects | NUMBER | |
| OTHER_PRE_SPECIFIED | Number of Subjects Who Develop Antibodies Against Bovine Aprotinin. | The antibody development was detected during Part 1 and Part 2 of the study up to 7 years | All participants enrolled in the study underwent to immunogenicity assessment. Participans in Part 1 was 11: 4 from Group 1A and 7 from Group 1B. Participants analysed in Part 2 was 11: 4 from Part 1-Group 1A, 6 from Part 1-Group 1B and 1 new patient enrolled directly in Part 2. | number of subjects | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Subjects Who Develop Antibodies Against Human Plasminogen. | The antibody development was detected during the Part 1 and Part 2 of the study, up to 7 years | number of subjects | NUMBER |
Source ClinicalTrials.gov
Results by group102
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Success to Prevent Pseudomembranes Relapse | Group 1A_mITT | success | 75 | 95% Confidence Interval 19.4 to 99.4 | percentage of eyes |
| Percentage of Success to Prevent Pseudomembranes Relapse | Group 1B_mITT | success | 81.8 | 95% Confidence Interval 48.2 to 97.7 | percentage of eyes |
| Percentage of Success to Prevent Pseudomembranes Relapse | Group 1A_PP | success | 100 | 95% Confidence Interval 29.2 to 100 | percentage of eyes |
| Percentage of Success to Prevent Pseudomembranes Relapse | Group 1B_PP | success | 100 | 95% Confidence Interval 66.4 to 100 | percentage of eyes |
| Percentage of Success to Prevent Pseudomembranes Relapse | Group 1A_mITT | partial success | 0 | 95% Confidence Interval 0 to 60.2 | percentage of eyes |
| Percentage of Success to Prevent Pseudomembranes Relapse | Group 1B_mITT | partial success | 18.2 | 95% Confidence Interval 2.3 to 51.8 | percentage of eyes |
| Percentage of Success to Prevent Pseudomembranes Relapse | Group 1A_PP | partial success | 0 | 95% Confidence Interval 0 to 70.8 | percentage of eyes |
| Percentage of Success to Prevent Pseudomembranes Relapse | Group 1B_PP | partial success | 0 | 95% Confidence Interval 0 to 33.6 | percentage of eyes |
| Percentage of Success to Prevent Pseudomembranes Relapse | Group 1A_mITT | failure | 25 | 95% Confidence Interval 0.6 to 80.6 | percentage of eyes |
| Percentage of Success to Prevent Pseudomembranes Relapse | Group 1B_mITT | failure | 0 | 95% Confidence Interval 0 to 28.5 | percentage of eyes |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1 (Segment 1 and Segment 2) | STARTED | Group 1A | 4 | 8 |
| Part 1 (Segment 1 and Segment 2) | STARTED | Group 1B | 7 | 14 |
| Part 1 (Segment 1 and Segment 2) | STARTED | Continuation Segment | 0 | 0 |
| Part 1 (Segment 1 and Segment 2) | COMPLETED | Group 1A | 4 | 8 |
| Part 1 (Segment 1 and Segment 2) | COMPLETED | Group 1B | 6 | 12 |
| Part 1 (Segment 1 and Segment 2) | COMPLETED | Continuation Segment | 0 | 0 |
| Part 1 (Segment 1 and Segment 2) | NOT COMPLETED | Group 1A | 0 | 0 |
| Part 1 (Segment 1 and Segment 2) | NOT COMPLETED | Group 1B | 1 | 2 |
| Part 1 (Segment 1 and Segment 2) | NOT COMPLETED | Continuation Segment | 0 | 0 |
| Part 2 (Continuation Segment) | STARTED | Group 1A | 4 | 8 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events333
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 | Hypertension | Vascular disorders | Group 1A | 0 | 4 | |
| other | Hypertension | Vascular disorders | Group 1B | 0 | 7 | |
| other | Hypertension | Vascular disorders | Continuation Segment | 1 | 11 | |
| other | Tooth extraction | Surgical and medical procedures | Group 1A | 0 | 4 | |
| other | Tooth extraction | Surgical and medical procedures | Group 1B | 0 | 7 | |
| other | Tooth extraction | Surgical and medical procedures | Continuation Segment | 1 | 11 | |
| other | Cholesteatoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Group 1A | 0 | 4 | |
| other | Cholesteatoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Group 1B | 0 | 7 | |
| other | Cholesteatoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Continuation Segment | 1 | 11 | |
| other | Multiple allergies | Immune system disorders | Group 1A | 0 | 4 |
1 to 10 of 333Source ClinicalTrials.gov
See all 333 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1A | 0 | 4 |
| Total, all-cause mortality | Group 1B | 0 | 7 |
| Total, all-cause mortality | Continuation Segment | 0 | 11 |
| Total, other adverse events | Group 1A | 4 | 4 |
| Total, other adverse events | Group 1B | 7 | 7 |
| Total, other adverse events | Continuation Segment | 10 | 11 |
| Total, serious adverse events | Group 1A | 2 | 4 |
| Total, serious adverse events | Group 1B | 3 | 7 |
| Total, serious adverse events | Continuation Segment | 3 | 11 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35346720 | DERIVED |
Source PubMed
Grants0
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.
None in this release.
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/NCT01554956
GET https://conductscience.org/api/trials/v1/NCT01554956/results?page=2